Surgical stapling instrument with a variable staple forming system

ABSTRACT

A surgical stapling instrument for use with an end effector that has an anvil that is movable relative to a staple cartridge supported in the end effector. The end effector is supported by an elongated shaft that extends from a handle assembly. The staple cartridge has a plurality of unformed staples therein that are formed when the anvil is moved into forming contact therewith. Movement of the anvil is controlled by a firing trigger on a handle assembly. The amount of staple formation achieved is dependent upon the degree to which the firing trigger has been actuated.

BACKGROUND

1. Technical Field

The present invention relates to surgical instruments and, in variousembodiments, to surgical cutting and stapling instruments and staplecartridges therefor that are designed to cut and staple tissue.

2. Background

Endoscopic surgical instruments are often preferred over traditionalopen surgical devices since a smaller incision tends to reduce thepost-operative recovery time and complications. Consequently,significant development has gone into a range of endoscopic surgicalinstruments that are suitable for precise placement of a distal endeffector at a desired surgical site through a cannula of a trocar. Thesedistal end effectors engage the tissue in a number of ways to achieve adiagnostic or therapeutic effect (e.g., endocutter, grasper, cutter,staplers, clip applier, access device, drug/gene therapy deliverydevice, and energy device using ultrasound, RF, laser, etc.).

In many endoscopic surgical applications, it is desirable to employ endeffectors that are only as large as necessary to complete a particularsurgical procedure. Smaller end effectors provide better visualizationof the surgical site. Smaller end effectors also allow for better accessand manipulation in tight spaces. Designers of such end effectors facemany challenges when trying to develop small end effectors. The abilityto manufacture small end effectors and, more particularly, smallendocutters that are designed to cut and staple tissue is hampered bythe magnitude of the actuation forces that are generally required toform lines of staples and cut tissue. Such actuation forces can alsovary with the thickness and composition of the tissue being treated. Forexample, larger actuation forces are commonly required to cut and staplethick tissues. Whereas, the magnitude of the actuation forces requiredto cut and staple thinner tissues in general are smaller. Thus, manyexisting endocutters typically employ robust anvil closure systems andstaple driving systems that are configured to accommodate a specificrange of tissue thicknesses. Such devices, however, are often notwell-suited for treating thinner tissues.

Prior endocutter devices also generally cut the tissue as the staplesare driven and formed in the tissue on each side of the cut. While suchdevices are very effective for those procedures that require the tissueto be cut and fastened, they do not provide the surgeon with the optionof installing fasteners without cutting tissue. Likewise, while variousforms of articulating endocutters have been developed to improve access,the components generally employed in such devices must be substantialenough to accommodate structures that can generate and transmitsufficient firing and closure forces to the end effector from the handleof the device. Thus, such end effectors are often too large toeffectively access tight spaces in the body.

Accordingly, there is a need for surgical cutting and staplinginstruments and staple cartridge arrangements that address many of thechallenges discussed above.

The foregoing discussion is intended only to illustrate some of theshortcomings present in the field of the invention at the time, andshould not be taken as a disavowal of claim scope.

SUMMARY

In at least one form, a surgical instrument is provided. In variousembodiments, the surgical instrument includes a handle assembly that hasan elongated shaft assembly operably coupled thereto. The elongatedshaft assembly has a distal end that is couplable to an end effectorthat supports a staple cartridge that supports a plurality of unformedstaples therein. The end effector further has an anvil that is movablefrom an open position wherein a staple forming surface of the anvil isspaced from the staple cartridge into closed positions wherein the anvilengages the staples therein. In various embodiments, the distance thatthe staple forming surface of the anvil travels into forming contactwith the staples in the staple cartridge is dependent upon a magnitudeof firing force applied thereto by a firing system that is at leastpartially supported in the elongated shaft assembly and the handleassembly. The firing system may be operated by a firing trigger that ismovably supported on the handle assembly such that the magnitude offiring force applied to the movable anvil is dependent upon a degree inwhich the firing trigger has been actuated on the handle assembly.

In accordance with other general aspects of at least one form, there isprovided an end effector for use in connection with a surgicalinstrument. In various implementations, the end effector comprises anelongated channel that is couplable to a portion of the surgicalinstrument. A staple cartridge is removably supported within theelongated channel. The staple cartridge comprises a plurality ofunformed staples supported within a compressible material. An anvil ismovably coupled to the elongated channel and has a staple formingsurface thereon. The anvil is configured to move from an open positionwherein the staple forming surface is spaced from the staple cartridgeinto compressing contact with the staple cartridge in response to amagnitude of firing motion applied thereto by the surgical instrumentsuch that as the magnitude of the firing motion increases, the stapleforming surface is further compressed into the staple cartridge intostaple forming contact with the staples therein.

In accordance with yet another general aspect of at least one form,there is provided a surgical instrument. In various embodiments, thesurgical instrument comprises a handle assembly that has a spine memberoperably coupled thereto. The spine member has a distal end that iscoupled to an elongated channel. A staple cartridge is removablysupported within the elongated channel and operably supports a pluralityof unformed staples therein. An anvil is movably coupled to theelongated channel and has a staple forming surface thereon. The anvil isconfigured to move from an open position wherein the staple formingsurface is spaced from the staple cartridge into compressing contactwith the staple cartridge in response to a magnitude of firing motionapplied thereto such that, as the magnitude of the firing motionincreases, the staple forming surface is further compressed into stapleforming contact with the staples in the staple cartridge. A firing tubeis movably supported on the spine member and has a distal end that isconfigured for engagement with the anvil such that the magnitude of thefiring force is increased as the distal end of the firing tube movesdistally into engagement with the anvil. A firing trigger is pivotallysupported on the handle assembly and interfaces with the firing tubesuch that the firing tube is moved distally on the spine member as thefiring trigger is pivoted.

BRIEF DESCRIPTION OF DRAWINGS

The above-mentioned and other features and advantages of this invention,and the manner of attaining them, will become more apparent and theinvention itself will be better understood by reference to the followingdescription of embodiments of the invention taken in conjunction withthe accompanying drawings, wherein:

FIG. 1 is a cross-sectional view of a surgical instrument embodiment ofthe present invention;

FIG. 1A is a perspective view of one embodiment of an implantable staplecartridge of the present invention;

FIG. 1B-1E illustrate portions of an end effector of various embodimentsof the present invention clamping and stapling tissue with animplantable staple cartridge embodiment of the present invention;

FIG. 2 is an exploded assembly view of an end effector embodiment and aportion of a surgical stapling instrument embodiment of the presentinvention shown in cross-section;

FIG. 3 is a side elevational view of an anvil embodiment of the presentinvention;

FIG. 4 is a is a cross-sectional view of a portion of the handleassembly depicted in FIG. 1;

FIG. 5 is a partial cross-sectional view of the handle assembly of FIG.1 taken along line 5-5 in FIG. 1;

FIG. 6 is a perspective view of a portion of firing transmissionembodiment of the present invention;

FIG. 7 is a partial cross-sectional view of the handle assembly of FIG.1 taken along line 7-7 in FIG. 1;

FIG. 8 is a partial cross-sectional view of a portion of the handleassembly of FIG. 7 taken along line 8-8- in FIG. 7;

FIG. 9 is a cross-sectional view of a surgical instrument embodiment ofthe present invention after an end effector has been coupled to a spineportion of the surgical instrument and prior to being locked thereto;

FIG. 9A is an enlarged view of the end effector and a portion of thesurgical instrument of FIG. 10;

FIG. 10 is a cross-sectional view of the surgical instrument of FIG. 9after the end effector has been locked to the spine portion of thesurgical instrument;

FIG. 10A is an enlarged view of the end effector and a portion of thesurgical instrument of FIG. 10;

FIG. 11 is a cross-sectional view of the surgical instrument of FIGS. 9and 10 after the first firing adapter has been advanced to the beginningof the clamping ramp portions of the anvil;

FIG. 11A is an enlarged view of the end effector and a portion of thesurgical instrument of FIG. 11 with tissue received between the anviland staple cartridge thereof;

FIG. 12 is a is a cross-sectional view of the surgical instrument ofFIGS. 9-11 after the first firing adapter has been advanced over theclamping ramp portions of the anvil;

FIG. 12A is an enlarged view of the end effector and a portion of thesurgical instrument of FIG. 12;

FIG. 13 is a cross-sectional view of the surgical instrument of FIGS.9-12 after the first firing adapter has been advanced over the stapleforming ramp to fully form the staples within the implantable staplecartridge;

FIG. 13A is an enlarged view of the end effector and a portion of thesurgical instrument of FIG. 13;

FIG. 14 is a cross-sectional view of the surgical instrument of FIGS.9-13 after the first firing adapter has been advanced over the stapleforming ramp to fully form the staples within the implantable staplecartridge and after the knife bar has been longitudinally advancedthrough the end effector;

FIG. 14A is an enlarged view of the end effector and a portion of thesurgical instrument of FIG. 14;

FIG. 15 is an exploded view of another end effector embodiment of thepresent invention with a portion of the spine member of a surgicalinstrument embodiment of the present invention shown in cross-section;

FIG. 16 is a partial cross-sectional view of the end effector embodimentof FIG. 15 in the open position and attached to the surgical instrumentembodiment;

FIG. 17 is another partial cross-sectional view of the end effectorembodiment of FIGS. 15 and 16 in the fully clamped position;

FIG. 18 is another partial cross-sectional view of the end effectorembodiment of FIGS. 15-17 in the fully fired position and prior toadvancement of the distal knife member;

FIG. 19 is another partial cross-sectional view of the end effectorembodiment of FIGS. 15-18 in the fully fired position and after completeadvancement of the distal knife member;

FIG. 20 is a cross-sectional view of a portion of another handleassembly embodiment of the present invention;

FIG. 21 is a partial cross-sectional view of a portion of the handleassembly of FIG. 20 taken along line 21-21 in FIG. 20;

FIG. 22 is a partial cross-sectional view of a portion of the handleassembly of FIG. 20 taken along line 22-22 in FIG. 20;

FIG. 23 is a partial cross-sectional view of a portion of the handleassembly of FIG. 20 taken along line 23-23 in FIG. 20;

FIG. 24 is a cross-sectional view of a portion of another handleassembly embodiment of the present invention;

FIG. 25 is a partial cross-sectional side view of another end effectorembodiment of the present invention coupled to a portion of a surgicalinstrument embodiment of the present invention with the end effectorsupporting a surgical staple cartridge embodiment of the presentinvention and with the anvil thereof in an open position;

FIG. 26 is another partial cross-sectional side view of the end effectorof FIG. 25 in a closed position;

FIG. 27 is another partial cross-sectional side view of the end effectorof FIGS. 25 and 26 as the knife bar is starting to advance through theend effector;

FIG. 28 is another partial cross-sectional side view of the end effectorof FIGS. 25-27 with the knife bar partially advanced therethrough;

FIG. 29 is a partial cross-sectional side view of another end effectorembodiment of the present invention coupled to a portion of a surgicalinstrument embodiment of the present invention with the end effectorsupporting another surgical staple cartridge embodiment of the presentinvention and with the anvil thereof in an open position;

FIG. 30 is another partial cross-sectional side view of the end effectorof FIG. 29 with the knife bar partially advanced therethrough;

FIG. 31 is a cross-sectional view of another surgical instrumentembodiment of the present invention with the anvil of the end effectorthereof in an open position;

FIG. 32 is an exploded assembly view of the end effector embodiment anda portion of the surgical stapling instrument embodiment of FIG. 31shown in cross-section;

FIG. 33 is a top view of the end effector and a portion of the elongatedshaft assembly of the surgical instrument of FIG. 31 with portionsthereof shown in cross-section taken along line 33-33 in FIG. 31;

FIG. 34 is a top view of the end effector and a portion of the elongatedshaft assembly of the surgical instrument of FIG. 31 with portionsthereof shown in cross-section;

FIG. 35 is another top view of the end effector and a portion of theelongated shaft assembly of the surgical instrument of FIG. 31 with theend effector in articulated orientation and with the end effector in anopen position;

FIG. 36 is another top view of the end effector of FIG. 35 with the endeffector in a closed or clamped position;

FIG. 37 is an enlarged view of a portion of the end effector andsurgical instrument embodiment depicted in FIG. 36;

FIG. 38 is a cross-sectional view of a portion of the handle assembly ofthe surgical instrument of FIG. 31;

FIG. 39 is another cross-sectional view of the portion of the handleassembly of FIG. 38 taken along line 39-39 in FIG. 38;

FIG. 40 is a partial perspective exploded view of an articulation balland socket arrangement of various embodiments of the present invention;

FIG. 41 is a top view of an end effector and a portion of an elongatedshaft assembly of another surgical instrument embodiment of the presentinvention in an unarticulated orientation;

FIG. 42 is another top view of the end effector and portion of elongatedshaft assembly of FIG. 41 in an articulated position;

FIG. 43 is cross-sectional view of another surgical instrumentembodiment of the present invention;

FIG. 44 is partial cross-sectional view of a portion of the articulatedshaft assembly of the surgical instrument embodiment of FIG. 43;

FIG. 44A is a cross-sectional view of a portion of the articulated shaftassembly of FIG. 44;

FIG. 44B is another cross-sectional view of another portion of thearticulated shaft assembly of FIG. 44;

FIG. 44C is another cross-sectional view of another portion of thearticulated shaft assembly of FIG. 44;

FIG. 44D is another cross-sectional view of another portion of thearticulated shaft assembly of FIG. 44;

FIG. 44E is another cross-sectional view of another portion of thearticulated shaft assembly of FIG. 44;

FIG. 44F is another cross-sectional view of another portion of thearticulated shaft assembly of FIG. 44;

FIG. 45 is a partial cross-sectional view of the articulated shaftassembly of FIG. 44 taken along line 45-45 in FIG. 44;

FIG. 46 is a partial cross-sectional view of the articulated shaftassembly of FIG. 44 taken along line 46-46 in FIG. 44;

FIG. 47 is another cross-sectional view of the surgical instrument ofFIG. 43 with the end effector thereof shown in a fully articulatedposition;

FIG. 48 is a cross-sectional view of the end effector of FIG. 47 with abellows-like cover extending over the articulation joint;

FIG. 49 is a cross-section view of a handle assembly of another surgicalinstrument embodiment of the present invention;

FIG. 50 is a cross-sectional exploded assembly view of an end effectorand the distal end of the elongated shaft assembly of FIG. 49;

FIG. 51 is another cross-sectional view of the end effector and portionof elongated shaft assembly of FIG. 50 with the end effector in an openposition;

FIG. 52 is another cross-sectional view of the end effector and portionof the elongated shaft assembly with the end effector in a closedposition;

FIG. 53 is another cross-sectional view of the end effector and portionof the elongated shaft of FIGS. 49-52 with the knife member in a fullyfired position;

FIG. 54 is a perspective view of the end effector of FIGS. 51-53 in anopen position;

FIG. 55 is a cross-sectional view of the end effector of FIGS. 51-54taken along line 55-55 in FIG. 51;

FIG. 56 is a partial perspective view of an elongated shaft assembly ofanother embodiment of the present invention attached to an end effectorembodiment of the present invention;

FIG. 57 is a partial cross-sectional view of a handle assembly ofanother surgical instrument embodiment of the present invention;

FIG. 58 is a cross-sectional view of a portion of the elongated shaftassembly of FIGS. 56 and 57 taken along line 58-58 in FIG. 57;

FIG. 59 is an enlarged view of a portion of the handle assembly of FIG.57;

FIG. 60 is a cross-sectional view of a distal end portion of theelongated shaft assembly of FIGS. 56-59;

FIG. 61 is a partial perspective view of an elongated shaft assembly ofanother embodiment of the present invention attached to an end effectorembodiment of the present invention;

FIG. 62 is a cross-sectional view of a portion of a reconfigurable shaftsegment of the elongated shaft of FIG. 61;

FIG. 63 is a partial perspective view of an elongated shaft assembly ofanother embodiment of the present invention attached to an end effectorembodiment of the present invention;

FIG. 64 is a cross-sectional view of a handle assembly of anothersurgical instrument embodiment of the present invention;

FIG. 65 is a cross-sectional view of a portion of the elongated shaftassembly of FIGS. 63 and 64 taken along line 65-65 in FIG. 64;

FIG. 66 is an enlarged view of a portion of the handle assembly of FIG.64;

FIG. 67 is a cross-sectional view of a portion of the reconfigurableshaft segment depicted in FIG. 63 with the tubular link portions thereofaligned in a substantially straight line;

FIG. 68 is a cross-sectional view of a portion of the reconfigurableshaft segment depicted in FIGS. 63 and 67 with the tubular link portionsthereof aligned in a substantially curved (non-coaxial) orientation;

FIG. 69 is a perspective view of an alternative staple cartridgeembodiment of the present invention installed in a surgical cutting andstapling device embodiment of the present invention;

FIG. 70 is a top view of the surgical staple cartridge and elongatedchannel of the device depicted in FIG. 69;

FIG. 71 is a top view of another surgical staple cartridge embodiment ofthe present invention installed in an elongated channel of an endeffector embodiment of the present invention;

FIG. 72 is a bottom view of an anvil embodiment of the presentinvention;

FIG. 73 is a partial perspective view of a plurality of staples forminga portion of a staple line embodiment of the present invention;

FIG. 74 is another partial perspective view of the staple lineembodiment of FIG. 73 with the staples thereof after being formed bybeing contacted by the anvil of the surgical cutting and staplingdevice;

FIG. 75 is a partial perspective view of alternative staples forming aportion of another staple line embodiment of the present invention;

FIG. 76 is a partial perspective view of alternative staples forming aportion of another staple line embodiment of the present invention;

FIG. 77 is a partial perspective view of alternative staples forming aportion of another staple line embodiment of the present invention;

FIG. 78 is a cross-sectional view of an end effectors embodiment of thepresent invention supporting a staple cartridge embodiment of thepresent invention;

FIG. 79 is a cross-sectional view of the elongated channel portion ofthe end effector of FIG. 78 after the implantable staple cartridge bodyportion and staples have been removed therefrom;

FIG. 80 is a cross-sectional view of an end effectors embodiment of thepresent invention supporting another staple cartridge embodiment of thepresent invention;

FIG. 81 is a partial cross-sectional view of a surgical staplinginstrument embodiment of the present invention with a staple cartridgesupported in the end effector thereof to move the cartridge lockingsystem to an unlocked position;

FIG. 82 is another partial cross-sectional view of the surgical staplinginstrument of FIG. 81 with the staple cartridge being removed from theend effector and the cartridge locking system in a locked position;

FIGS. 83A-83D diagram the deformation of a surgical staple positionedwithin a collapsible staple cartridge body in accordance with at leastone embodiment;

FIG. 84A is a diagram illustrating a staple positioned in a crushablestaple cartridge body;

FIG. 84B is a diagram illustrating the crushable staple cartridge bodyof FIG. 84A being crushed by an anvil;

FIG. 84C is a diagram illustrating the crushable staple cartridge bodyof FIG. 84A being further crushed by the anvil;

FIG. 84D is a diagram illustrating the staple of FIG. 84A in a fullyformed configuration and the crushable staple cartridge of FIG. 84A in afully crushed condition;

FIG. 85 is a diagram depicting a staple positioned against a staplecartridge support surface and illustrating potential relative movementtherebetween;

FIG. 86 is a cross-sectional view of a staple cartridge support surfacecomprising a slot, or trough, configured to stabilize the base of thestaple of FIG. 85;

FIG. 87 is a cross-sectional view of a staple comprising an overmoldedcrown and a slot, or trough, configured to receive a portion of thecrown in accordance with at least one alternative embodiment;

FIG. 88 is a top view of a staple cartridge in accordance with at leastone embodiment comprising staples embedded in a collapsible staplecartridge body;

FIG. 89 is an elevational view of the staple cartridge of FIG. 88;

FIG. 90 is an elevational view of a staple cartridge in accordance withat least one embodiment comprising a protective layer surroundingstaples positioned within a collapsible staple cartridge body;

FIG. 91 is a cross-sectional view of the staple cartridge of FIG. 90taken along line 91-91 in FIG. 90;

FIG. 92 is an elevational view of a staple cartridge in accordance withat least one embodiment comprising staples at least partially extendingoutside of a collapsible staple cartridge body and a protective layersurrounding the staple cartridge body;

FIG. 93 is a cross-sectional view of the staple cartridge of FIG. 92taken along line 93-93 in FIG. 92;

FIG. 94 is a partial break-away view of a staple cartridge in accordancewith at least one embodiment comprising staples at least partiallyembedded in a collapsible staple cartridge body, the staples being atleast partially positioned in a staple cavity void in the staplecartridge body;

FIG. 95 is a cross-sectional view of the staple cartridge of FIG. 94taken along line 95-95 in FIG. 94;

FIG. 96 is a partial break-away view of a staple cartridge in accordancewith at least one embodiment;

FIG. 97 is a partial break-away view of a staple cartridge in accordancewith at least one embodiment comprising staples at least partiallyembedded within a collapsible staple cartridge body and an alignmentmatrix connecting the staples and aligning the staples with respect toeach other;

FIG. 98 is a cross-sectional view of the staple cartridge of FIG. 97taken along line 98-98 in FIG. 97;

FIG. 99 is partial cut-away view of an inner layer of a compressiblestaple cartridge body;

FIG. 100 is a diagram illustrating the inner layer of FIG. 99 compressedbetween a transfer plate and a support plate;

FIG. 101 is a diagram illustrating staples being inserted into thecompressed inner layer of FIG. 100;

FIG. 102 is a diagram of the support plate of FIG. 100 being removedaway from the inner layer;

FIG. 103 is a diagram of a subassembly comprising the inner layer ofFIG. 99 and the staples of FIG. 101 being inserted into an outer layer;

FIG. 104 is a diagram illustrating the outer layer of FIG. 103 beingsealed to form a sealed staple cartridge;

FIG. 105 is a cross-sectional view of the sealed staple cartridge ofFIG. 104;

FIG. 106 is a cross-sectional view of a staple cartridge and staplecartridge channel in accordance with at least one embodiment;

FIG. 107 is a diagram illustrating a portion of the staple cartridge ofFIG. 106 in a deformed state;

FIG. 108 is an elevational view of an end effector of a surgical staplercomprising an anvil in an open position and a staple cartridgepositioned within a staple cartridge channel;

FIG. 109 is an elevational view of the end effector of FIG. 108illustrating the anvil in a closed position and the staple cartridgecompressed between the anvil and the staple cartridge channel;

FIG. 110 is an elevational view of the end effector of FIG. 108illustrating the staple cartridge of FIG. 108 positioned within thestaple cartridge channel in an alternative manner;

FIG. 111 is a cross-sectional view of an end effector of a surgicalstapler comprising a compressible staple cartridge positioned within astaple cartridge channel and a piece of buttress material attached to ananvil;

FIG. 112 is a cross-sectional view of the end effector of FIG. 111illustrating the anvil in a closed position;

FIG. 113 is a cross-sectional view of an alternative embodiment of anend effector of a surgical stapler comprising a staple cartridgecomprising a water impermeable layer;

FIG. 114 is a cross-sectional view of another alternative embodiment ofan end effector of a surgical stapler;

FIG. 115 is a cross-sectional view of an alternative embodiment of anend effector of a surgical stapler comprising a stepped anvil and astaple cartridge comprising a stepped cartridge body;

FIG. 116 is a cross-sectional view of another alternative embodiment ofan end effector of a surgical stapler;

FIG. 117 is a cross-sectional view of an alternative embodiment of anend effector of a surgical stapler comprising inclined tissue-contactingsurfaces;

FIG. 118 is a cross-sectional view of another alternative embodiment ofan end effector of a surgical stapler comprising inclinedtissue-contacting surfaces;

FIG. 119 is a cross-sectional view of an alternative embodiment of anend effector of a surgical stapler comprising a support insertconfigured to support a staple cartridge;

FIG. 120 is a cross-sectional view of an alternative embodiment of anend effector of a surgical stapler comprising a staple cartridgecomprising a plurality of compressible layers;

FIG. 121 is a cross-sectional view of an alternative embodiment of anend effector of a surgical stapler comprising a staple cartridgecomprising a stepped compressible cartridge body;

FIG. 122 is a cross-sectional view of another alternative embodiment ofan end effector of a surgical stapler comprising a staple cartridgecomprising a stepped compressible cartridge body;

FIG. 123 is a cross-sectional view of an alternative embodiment of anend effector of a surgical stapler comprising a staple cartridgecomprising a curved tissue-contacting surface;

FIG. 124 is a cross-sectional view of an alternative embodiment of anend effector of a surgical stapler comprising a staple cartridge havingan inclined tissue-contacting surface;

FIG. 125 is a cross-sectional view of a compressible staple cartridgecomprising staples and at least one medicament stored therein;

FIG. 126 is a diagram illustrating the compressible staple cartridge ofFIG. 125 after it has been compressed and the staples contained thereinhave been deformed;

FIG. 127 is a partial cut-away view of a staple cartridge in accordancewith at least one embodiment;

FIG. 128 is a cross-sectional view of the staple cartridge of FIG. 127;

FIG. 129 is a perspective view of an implanted staple cartridge inaccordance with at least one alternative embodiment;

FIG. 130 is a cross-sectional view of the implanted staple cartridge ofFIG. 129;

FIG. 131 is a perspective view of an alternative embodiment of a staplecartridge comprising deformable members extending from an outer layer ofthe staple cartridge;

FIG. 132 is a perspective view of an alternative embodiment of a staplecartridge comprising an outer layer of the staple cartridge beingassembled to an inner layer;

FIG. 133 is a cross-sectional view of an alternative embodiment of astaple cartridge comprising a plurality of staples, a compressiblelayer, and a pledget layer;

FIG. 134 is a perspective view of the pledget layer of FIG. 133;

FIG. 135 is a perspective view of a pledget singulated from the pledgetlayer of FIG. 133 and a staple aligned with a groove in the pledget;

FIG. 136 is a perspective view of two connected pledgets from thepledget layer of FIG. 133;

FIG. 137 is a perspective view of a pledget support frame of the pledgetlayer of FIG. 133 being removed from the singulated pledgets;

FIG. 138 is an exploded perspective view of an alternative embodiment ofa compressible staple cartridge comprising staples therein and a systemfor driving the staples against an anvil;

FIG. 138A is a partial cut-away view of an alternative embodiment of thestaple cartridge of FIG. 138;

FIG. 139 is a cross-sectional view of the staple cartridge of FIG. 138;

FIG. 140 is an elevational view of a sled configured to traverse thestaple cartridge of FIG. 138 and move the staples to toward the anvil;

FIG. 141 is a diagram of a staple driver which can be lifted toward theanvil by the sled of FIG. 140;

FIG. 142 is a break-away view of a staple cartridge in accordance withat least one alternative embodiment comprising staples positioned withinstaple drivers;

FIG. 143 is a cross-sectional view of the staple cartridge of FIG. 142positioned within a staple cartridge channel;

FIG. 144 is a cross-sectional view of the staple cartridge of FIG. 142illustrating an anvil moved into a closed position and staples containedwithin the staple cartridge deformed by the anvil;

FIG. 145 is a cross-sectional view of the staple cartridge of FIG. 142illustrating the staples moved upwardly toward the anvil;

FIG. 146 is a perspective view of an alternative embodiment of a staplecartridge comprising straps connecting the flexible sides of the staplecartridge;

FIG. 147 is a perspective view of a sled and cutting member assembly;

FIG. 148 is a diagram of the sled and cutting member assembly of FIG.147 being used to lift the staples of the staple cartridge of FIG. 142;

FIG. 149 is a diagram illustrating a sled configured to engage and liftstaples toward an anvil and a lock-out system configured to selectivelypermit the sled to move distally;

FIGS. 150A-150C illustrate the progression of a staple being insertedinto a staple crown;

FIG. 151 is a cross-sectional view of a staple cartridge comprising asupport pan or retainer;

FIG. 152 is a partial cross-sectional view of a compressible staplecartridge in accordance with at least one alternative embodiment;

FIG. 153 is a diagram illustrating the staple cartridge of FIG. 152 inan implanted condition;

FIG. 154 is a partial cut-away view of a compressible staple cartridgein accordance with at least one alternative embodiment;

FIG. 155 is a partial cross-sectional view of the staple cartridge ofFIG. 154;

FIG. 156 is a diagram illustrating the staple cartridge of FIG. 154 inan implanted condition;

FIG. 157 is a partial cross-sectional view of a crushable staplecartridge in accordance with at least one alternative embodiment;

FIG. 158 is a partial cut-away view of a collapsible staple cartridge inaccordance with at least one embodiment comprising a plurality ofcollapsible elements;

FIG. 159 is a perspective view of a collapsible element of FIG. 158 inan uncollapsed state;

FIG. 160 is a perspective view of the collapsible element of FIG. 159 ina collapsed state;

FIG. 161A is a partial cross-sectional view of an end effector of asurgical stapling instrument comprising a jaw, a staple cartridgechannel positioned opposite the jaw, and a staple cartridge positionedwithin the staple cartridge channel, wherein the jaw comprises aretention matrix attached thereto;

FIG. 161B is a partial cross-sectional view of the end effector of FIG.161A illustrating the jaw being moved toward the staple cartridgechannel, the staple cartridge being compressed by the anvil and theretention matrix, and a staple at least partially extending throughtissue positioned intermediate the retention matrix and the staplecartridge;

FIG. 161C is a partial cross-sectional view of the end effector of FIG.161A illustrating the jaw in a final position and the retention matrixengaged with the staple of FIG. 161B;

FIG. 161D is a partial cross-sectional view of the end effector of FIG.161A illustrating the jaw and the staple cartridge channel being movedaway from the implanted staple cartridge and retention matrix;

FIG. 162 is a perspective view of a retention aperture of a retentionmatrix in accordance with at least one alternative embodiment comprisinga plurality of retention members configured to engage a fastener legextending therethrough;

FIG. 163 is a perspective view of a retention aperture of a retentionmatrix in accordance with at least one alternative embodiment comprisingsix retention members;

FIG. 164 is a perspective view of a retention aperture of a retentionmatrix in accordance with at least one alternative embodiment comprisingeight retention members;

FIG. 165 is a perspective view of a retention aperture of a retentionmatrix in accordance with at least one alternative embodiment comprisinga plurality of retention members configured to engage a fastener legextending therethrough;

FIG. 166 is a perspective view of a retention aperture of a retentionmatrix in accordance with at least one alternative embodiment comprisingsix retention members;

FIG. 167 is a perspective view of a retention aperture of a retentionmatrix in accordance with at least one alternative embodiment comprisingeight retention members;

FIG. 168 is a perspective view of a retention aperture of a retentionmatrix in accordance with at least one alternative embodiment comprisinga plurality of retention members that have been stamped from a sheet ofmetal;

FIG. 169 is a perspective view of a retention aperture of a retentionmatrix in accordance with at least one alternative embodiment comprisinga plurality of apertures extending around the perimeter of the retentionaperture;

FIG. 170 is a top view of a retention aperture of a retention matrix inaccordance with at least one alternative embodiment;

FIG. 171 is a top view of a retention aperture of a retention matrix inaccordance with at least one alternative embodiment;

FIG. 172 is a top view of a retention aperture of a retention matrix inaccordance with at least one alternative embodiment;

FIG. 173 is a top view of a retention aperture of a retention matrix inaccordance with at least one alternative embodiment;

FIG. 174 is a top view of a retention aperture of a retention matrix inaccordance with at least one alternative embodiment;

FIG. 175 is a top view of a retention aperture of a retention matrixcomprising a retention tab extending into the retention aperture inaccordance with at least one embodiment;

FIG. 176 is a top view of a retention aperture of a retention matrixcomprising a retention tab extending into the retention aperture inaccordance with at least one alternative embodiment;

FIG. 177 is a perspective view of a fastening system comprising aplurality of staples, a retention matrix engaged with the staples, andan alignment matrix configured to align the staples;

FIG. 178 is a perspective view of the retention matrix of FIG. 177;

FIG. 179 is a perspective view of the alignment matrix of FIG. 177;

FIG. 180 is a partial top view of the retention matrix of FIG. 177engaged with the staples of FIG. 177;

FIG. 181 is a partial bottom view of the retention matrix of FIG. 177engaged with the staples of FIG. 177;

FIG. 182 is a partial elevational view of the fastening system of FIG.177;

FIG. 183 is a partial perspective view of the fastening system of FIG.177;

FIG. 184 is a partial cross-sectional view of the retention matrix ofFIG. 177 engaged with the staples of FIG. 177;

FIG. 185 is a partial cross-sectional view of the fastening system ofFIG. 177;

FIG. 186 is a perspective view of the fastening system of FIG. 177further comprising protective caps assembled to the legs of the staples;

FIG. 187 is a bottom perspective view of the fastening systemarrangement of FIG. 186;

FIG. 188 is a partial perspective view of the fastening systemarrangement of FIG. 186;

FIG. 189 is a partial cross-sectional view of the fastening systemarrangement of FIG. 186;

FIG. 190 is an elevational view of an end effector in accordance with atleast one embodiment comprising a jaw in an open position, a retentionmatrix and a plurality of protective caps positioned in the jaw, and astaple cartridge positioned in a staple cartridge channel;

FIG. 191 is an elevational view of the end effector of FIG. 190 in aclosed position;

FIG. 192 is an elevational view of the end effector of FIG. 190 in afired position;

FIG. 193 is an elevational view of the retention matrix and protectivecaps of FIG. 190 assembled to the staple cartridge of FIG. 190;

FIG. 194 is a detail view of the arrangement of FIG. 193;

FIG. 195 is an elevational view of the end effector of FIG. 190illustrating the jaw in an open position with thinner tissue positionedbetween the retention matrix and the staple cartridge;

FIG. 196 is an elevational view of the end effector of FIG. 190illustrating the jaw in a closed position against the thinner tissue ofFIG. 195;

FIG. 197 is an elevational view of the end effector of FIG. 190illustrating the jaw in a fired position to capture the thinner tissueof FIG. 195 between the retention matrix and the staple cartridge;

FIG. 198 is an elevational view of the retention matrix and theprotective caps of FIG. 190 assembled to the staple cartridge of FIG.190 with the thin tissue of FIG. 195 positioned therebetween;

FIG. 199 is a detail view of the arrangement of FIG. 198;

FIG. 200 is a cross-sectional view of a protective cap positioned on thetip of a staple leg in accordance with at least one alternativeembodiment;

FIG. 201 is a perspective view of a plurality of protective capsembedded within a sheet of material;

FIG. 202 is a perspective view of a jaw comprising a plurality ofrecesses configured to receive a plurality of protective caps therein;

FIG. 203 is a detail view of a portion of a jaw comprising a sheetcovering the protective caps positioned within the jaw of FIG. 202;

FIG. 204 is a cross-sectional view of a protective cap positioned on atip of a staple leg in accordance with at least one alternativeembodiment wherein the protective cap comprises an interior formingsurface;

FIG. 205 is another cross-sectional view of the protective cap of FIG.204 illustrating the staple leg being deformed against the formingsurface;

FIG. 206 is a top view of an alternative embodiment of a retentionmatrix comprising a plurality of connected matrix elements;

FIG. 207 is a top view of an alternative embodiment of a retentionmatrix comprising a plurality of connected matrix elements;

FIG. 208 is a top view of an alternative embodiment of a retentionmatrix comprising a plurality of connected matrix elements;

FIG. 209 is a top view of an alternative embodiment of an array ofretention matrices comprising a plurality of connected matrix elements;

FIG. 210 is a top view of an alternative embodiment of a retentionmatrix comprising a plurality of connected matrix elements;

FIG. 211 is a partial exploded view of a jaw comprising a retentionmatrix including a compressible cover;

FIG. 212 is a detail view of the retention matrix of FIG. 211;

FIG. 213 is a partial cross-sectional view of a fastening systemcomprising a retention matrix including a compressible layer and aplurality of cells encapsulating one or more medicaments;

FIG. 214 is a diagram illustrating staple legs which have pierced thecells of FIG. 213 as they are being engaged with the retention matrix;

FIG. 215 is a partial cross-sectional view of a fastening systemcomprising a retention matrix including a compressible layer;

FIG. 216 is an elevational view of a fastener cartridge insertionassembly comprising a holder, a first fastener cartridge, and a secondfastener cartridge;

FIG. 217 is an elevational view of an end effector of a surgical staplercomprising a first jaw and a second jaw, the second jaw beingillustrated in an open configuration;

FIG. 218 is an elevational view of the end effector of FIG. 217illustrating the second jaw in a closed configuration and the fastenercartridge insertion assembly of FIG. 216 being used to load the firstjaw with the first cartridge and the second jaw with the secondcartridge;

FIG. 219 is an elevational view of the loaded end effector of FIG. 218illustrating the cartridge insertion assembly removed from the endeffector, the second jaw in an open configuration once again, and tissuepositioned intermediate the first jaw and the second jaw;

FIG. 220 is an elevational view of the loaded end effector of FIG. 219in a fired configuration;

FIG. 221 is an elevational view of the first cartridge and the secondcartridge in an implanted condition;

FIG. 222 is an elevational view of the end effector of FIG. 217illustrating a portion of the first cartridge still engaged with thefirst jaw in accordance with at least one embodiment;

FIG. 223 is an elevational view of an alternative embodiment of afastener cartridge insertion assembly comprising a holder, a firstfastener cartridge, and a second fastener cartridge;

FIG. 224 is an elevational view of the fastener cartridge insertionassembly of FIG. 223 being used to load a first jaw of an end effectorwith the first cartridge and a second jaw with the second cartridge;

FIG. 225 is a cross-sectional view of the loaded end effector of FIG.224;

FIG. 226 is a perspective view of a surgical stapler comprising a bottomjaw and a top jaw in accordance with at least one embodiment illustratedwith portions of the surgical stapler removed;

FIG. 227 is a perspective view of the surgical stapler of FIG. 226 withthe top jaw removed;

FIG. 228 is a perspective view of a slidable anvil system of the top jawof the surgical stapler of FIG. 226 comprising a first slidable anviland a second slidable anvil;

FIG. 229 is an end view of the slidable anvil system of FIG. 228;

FIG. 230 is a top view of the slidable anvil system of FIG. 228;

FIG. 231 is a diagram illustrating the slidable anvil system of FIG. 228in an unfired condition;

FIG. 232 is a diagram illustrating the first slidable anvil of theslidable anvil system of FIG. 228 in an unfired position and staplespositioned within the bottom jaw in an undeployed position;

FIG. 233 is a diagram illustrating the staples in the bottom jaw in adeployed configuration and the first slidable anvil of FIG. 232 beingpulled proximally to deform a first group of staple legs of the staples;

FIG. 234 is a diagram illustrating the first group of staples of FIG.233 deformed to a fully deformed state;

FIG. 235 is a diagram illustrating the second slidable anvil of theslidable anvil system of FIG. 228 being pushed distally to deform asecond group of staple legs;

FIG. 236 is a partial perspective view of an anvil comprising aplurality of forming pockets in at least one embodiment;

FIG. 237 is a cross-sectional end view of the anvil of FIG. 236;

FIG. 238 is a diagram illustrating a first step in manufacturing theforming pockets of FIG. 236;

FIG. 239 is a diagram illustrating a second step in manufacturing theforming pockets of FIG. 236;

FIG. 240 is a top view of the forming pocket arrangement of the anvil ofFIG. 236;

FIG. 241 is a diagram illustrating a first step of a manufacturingprocess for producing an anvil;

FIG. 242 is a diagram illustrating a second step in the manufacturingprocess of FIG. 241; and

FIG. 243 is a diagram illustrating a third step in the manufacturingprocess of FIG. 241.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate preferred embodiments of the invention, in one form, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DETAILED DESCRIPTION

The Applicant of the present application also owns the U.S. patentapplications identified below which were filed on even date herewith andwhich are each herein incorporated by reference in their respectiveentirety:

U.S. patent application Ser. No. ______, entitled “Surgical StaplingInstrument With Interchangeable Staple Cartridge Arrangements”, AttorneyDocket No. END6849USNP/100534;

U.S. patent application Ser. No. ______, entitled “Surgical Cutting andFastening Instruments With Separate and Distinct Fastener Deployment andTissue Cutting Systems”, Attorney Docket No. END6839USNP/100524;

U.S. patent application Ser. No. ______, entitled “Surgical StaplingInstrument With Compact Articulation Control Arrangement”, AttorneyDocket No. END6847USNP/100532;

U.S. patent application Ser. No. ______, entitled “Jaw ClosureArrangements For Surgical Instruments”, Attorney Docket No.END6736USNP/100060;

U.S. patent application Ser. No. ______, entitled “Surgical InstrumentsWith Reconfigurable Shaft Segments”, Attorney Docket No.END6734USNP/100058;

U.S. patent application Ser. No. ______, entitled “Surgical StapleCartridges Supporting Non-Linearly Arranged Staples and SurgicalStapling Instruments With Common Staple-Forming Pockets”, AttorneyDocket No. END6735USNP/100059;

U.S. patent application Ser. No. ______, entitled “Surgical StapleCartridges With Detachable Support Structures and Surgical StaplingInstruments With Systems For Preventing Actuation Motions When aCartridge is Not Present”, Attorney Docket No. END6855USNP/100540;

U.S. patent application Ser. No. ______, entitled “Implantable FastenerCartridge Having a Non-Uniform Arrangement”, Attorney Docket No.END6840USNP/100525;

U.S. patent application Ser. No. ______, entitled “Implantable FastenerCartridge Comprising a Support Retainer”, Attorney Docket No.END6841USNP/100526;

U.S. patent application Ser. No. ______, entitled “Implantable FastenerCartridge Comprising Multiple Layers”, Attorney Docket No.END6842USNP/100527;

U.S. patent application Ser. No. ______, entitled “SelectivelyOrientable Implantable Fastener Cartridge”, Attorney Docket No.END6843USNP/100528;

U.S. patent application Ser. No. ______, entitled “Implantable FastenerCartridge Comprising Bioabsorbable Layers”, Attorney Docket No.END6856USNP/100541;

U.S. patent application Ser. No. ______, entitled “Compressible FastenerCartridge”, Attorney Docket No. END6857USNP/100542;

U.S. patent application Ser. No. ______, entitled “Fasteners SupportedBy a Fastener Cartridge Support”, Attorney Docket No.END6858USNP/100543;

U.S. patent application Ser. No. ______, entitled “Collapsible FastenerCartridge”, Attorney Docket No. END6859USNP/100544;

U.S. patent application Ser. No. ______, entitled “Fastener SystemComprising a Plurality of Connected Retention Matrix Elements”, AttorneyDocket No. END6860USNP/100546;

U.S. patent application Ser. No. ______, entitled “Fastener SystemComprising a Retention Matrix and an Alignment Matrix”, Attorney DocketNo. END6861USNP/100547;

U.S. patent application Ser. No. ______, entitled “Fastener SystemComprising a Retention Matrix”, Attorney Docket No. END6862USNP/100548;

U.S. patent application Ser. No. ______, entitled “Fastening InstrumentFor Deploying a Fastener System Comprising a Retention Matrix”, AttorneyDocket No. END6863USNP/100549;

U.S. patent application Ser. No. ______, entitled “Fastener SystemComprising a Retention Matrix and a Cover”, Attorney Docket No.END6864USNP/100550; and

U.S. patent application Ser. No. ______, entitled “Fastener SystemComprising a Plurality of Fastener Cartridges”, Attorney Docket No.END6865USNP/100551.

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the various embodiments of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment”, or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment”, or “in an embodiment”, or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation. Such modifications and variations are intended to beincluded within the scope of the present invention.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” referring to the portion closest to the clinicianand the term “distal” referring to the portion located away from theclinician. It will be further appreciated that, for convenience andclarity, spatial terms such as “vertical”, “horizontal”, “up”, and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

Various exemplary devices and methods are provided for performinglaparoscopic and minimally invasive surgical procedures. However, theperson of ordinary skill in the art will readily appreciate that thevarious methods and devices disclosed herein can be used in numeroussurgical procedures and applications including, for example, inconnection with open surgical procedures. As the present DetailedDescription proceeds, those of ordinary skill in the art will furtherappreciate that the various instruments disclosed herein can be insertedinto a body in any way, such as through a natural orifice, through anincision or puncture hole formed in tissue, etc. The working portions orend effector portions of the instruments can be inserted directly into apatient's body or can be inserted through an access device that has aworking channel through which the end effector and elongated shaft of asurgical instrument can be advanced.

Turning to the Drawings wherein like numerals denote like componentsthroughout the several views, FIG. 1 depicts a surgical instrument 10that is capable of practicing several unique benefits of the presentinvention. The surgical stapling instrument 10 is designed to manipulateand/or actuate various forms and sizes of end effectors 12 that areoperably attached thereto. In the embodiment depicted in FIGS. 1 and 2,for example, the end effector 12 includes an elongated channel 14 thatforms a lower jaw 13 of the end effector 12. The elongated channel 14 isconfigured to support an “implantable” staple cartridge 30 and alsomovably support an anvil 20 that functions as an upper jaw 15 of the endeffector 12.

In various embodiments, the elongated channel 14 may be fabricated from,for example, 300 & 400 Series, 17-4 & 17-7 stainless steel, titanium,etc. and be formed with spaced side walls 16. The anvil 20 may befabricated from, for example, 300 & 400 Series, 17-4 & 17-7 stainlesssteel, titanium, etc. and have a staple forming undersurface, generallylabeled as 22 that has a plurality of staple forming pockets 23 formedtherein. See FIGS. 1B-1E. In addition, the anvil 20 has a bifurcatedramp assembly 24 that protrudes proximally therefrom. An anvil pin 26protrudes from each lateral side of the ramp assembly 24 to be receivedwithin a corresponding slot or opening 18 in the side walls 16 of theelongated channel 14 to facilitate its movable or pivotable attachmentthereto.

Various forms of implantable staple cartridges may be employed with thevarious embodiments of the surgical instruments disclosed herein.Specific staple cartridge configurations and constructions will bediscussed in further detail below. However, in the embodiment depictedin FIGS. 1A and 9-14, an implantable staple cartridge 30 is shown. In atleast one embodiment, the staple cartridge 30 has a body portion 31 thatconsists of a compressible hemostat material such as, for example,oxidized regenerated cellulose (“ORC”) or a bio-absorbable foam in whichlines of unformed metal staples 32 are supported. In at least someembodiments, in order to prevent the staple from being affected and thehemostat material from being activated during the introduction andpositioning process, the entire cartridge may be coated or wrapped in abiodegradable film 38 such as a polydioxanon film sold under thetrademark PDS® or with a Polyglycerol sebacate (PGS) film or otherbiodegradable films formed from PGA (Polyglycolic acid, marketed underthe trade mark Vicryl), PCL (Polycaprolactone), PLA or PLLA (Polylacticacid), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold underthe trademark Monocryl) or a composite of PGA, PCL, PLA, PDS that wouldbe impermeable until ruptured. The body 31 of staple cartridge 30 issized to be removably supported within the elongated channel 14 as shownsuch that each staple 32 therein is aligned with corresponding stapleforming pockets 23 in the anvil when the anvil 20 is driven into formingcontact with the staple cartridge 30.

In use, once the end effector 12 has been positioned adjacent the targettissue, the end effector 12 is manipulated to capture or clamp thetarget tissue between an upper face 36 of the staple cartridge 30 andthe staple forming surface 22 of the anvil 20. The staples 32 are formedby moving the anvil 20 in a path that is substantially parallel to theelongated channel 14 to bring the staple forming surface 22 and, moreparticularly, the staple forming pockets 23 therein into substantiallysimultaneous contact with the upper face 36 of the staple cartridge 30.As the anvil 20 continues to move into the staple cartridge 30, the legs34 of the staples 32 contact a corresponding staple forming pocket 23 inanvil 20 which serves to bend the staple legs 34 over to form thestaples 32 into a “B shape”. Further movement of the anvil 20 toward theelongated channel 14 will further compress and form the staples 32 to adesired final formed height “FH”.

The above-described staple forming process is generally depicted inFIGS. 1B-1E. For example, FIG. 1B illustrates the end effector 12 withtarget tissue “T” between the anvil 20 and the upper face 36 of theimplantable staple cartridge 30. FIG. 1C illustrates the initialclamping position of the anvil 20 wherein the anvil has 20 been closedonto the target tissue “T” to clamp the target tissue “T” between theanvil 20 and the upper face 36 of the staple cartridge 30. FIG. 1Dillustrates the initial staple formation wherein the anvil 20 hasstarted to compress the staple cartridge 30 such that the legs 34 of thestaples 32 are starting to be formed by the staple forming pockets 23 inthe anvil 20. FIG. 1E illustrates the staple 32 in its final formedcondition through the target tissue “T” with the anvil 20 removed forclarity purposes. Once the staples 32 have been formed and fastened tothe target tissue “T”, the surgeon will move the anvil 20 to the openposition to enable the cartridge body 31 and the staples 32 to remainaffixed to the target tissue while the end effector 12 is beingwithdrawn from the patient. The end effector 12 forms all of the staplessimultaneously as the two jaws 13, 15 are clamped together. Theremaining “crushed” body materials 31 act as both a hemostat (the ORC)and a staple line reinforcement (PGA, PDS or any of the other filmcompositions mentioned above 38). Also, since the staples 32 never haveto leave the cartridge body 31 during forming, the likelihood of thestaples 32 being malformed during forming is minimized. As used hereinthe term “implantable” means that, in addition to the staples, thecartridge body materials that support the staples will also remain inthe patient and eventually be absorbed by the patient's body. Suchimplantable staple cartridges are distinguishable from prior cartridgearrangements that remain with the end effector and are removedtherewith. Those “removable” staple cartridges typically include stapledriver components and therefore may be much larger than the endeffectors of the present invention that are designed to be employed inconnection with certain unique and novel implantable staple cartridgeembodiments of the present invention.

In various implementations, the end effector 12 is configured to becoupled to an elongated shaft assembly 40 that protrudes from a handleassembly 100. The end effector 12 (when closed) and the elongated shaftassembly 40 may have similar cross-sectional shapes and be sized tooperably pass through a trocar tube or working channel in another formof access instrument. As used herein, the term “operably pass” meansthat the end effector and at least a portion of the elongated shaftassembly may be inserted through or passed through the channel or tubeopening and can be manipulated therein as needed to complete thesurgical stapling procedure. In some embodiments, when in a closedposition, the jaws 13 and 15 of the end effector 12 may provide the endeffector with a roughly circular cross-sectional shape that facilitatesits passage through a circular passage/opening. However, the endeffectors of various embodiments of the present invention, as well asthe elongated shaft assembly embodiments, could conceivably be providedwith other cross-sectional shapes that could otherwise pass throughaccess passages and openings that have non-circular cross-sectionalshapes. Thus, an overall size of a cross-section of a closed endeffector will be related to the size of the passage or opening throughwhich it is intended to pass. Thus, one end effector for example, may bereferred to as a “5 mm” end effector which means it can operably passthrough an opening that is at least approximately 5 mm in diameter.

In various embodiments of the present invention, the elongated shaftassembly 40 may have an outer diameter that is substantially the same asthe outer diameter of the end effector 12 when in a closed position. Forexample, a 5 mm end effector may be coupled to an elongated shaftassembly 40 that has 5 mm cross-sectional diameter. However, as thepresent Detailed Description proceeds, it will become apparent thatvarious embodiments of the present may be effectively used in connectionwith different sizes of end effectors. For example, a 10 mm end effectormay be attached to an elongated shaft that has a 5 mm cross-sectionaldiameter. Conversely, for those applications wherein a 10 mm or largeraccess opening or passage is provided, the elongated shaft assembly 40may have a 10 mm (or larger) cross-sectional diameter, but may also beable to actuate a 5 mm or 10 mm end effector. Accordingly, the outershaft 40 may have an outer diameter that is the same as or is differentfrom the outer diameter of a closed end effector 12 attached thereto.

As depicted, the elongated shaft assembly 40 extends distally from thehandle assembly 100 in a generally straight line to define alongitudinal axis A-A. In various embodiments, for example, theelongated shaft assembly 40 may be approximately 9-16 inches (229-406mm) long. However, the elongated shaft assembly 40 may be provided inother lengths and, in other embodiments, may have joints therein or beotherwise configured to facilitate articulation of the end effector 12relative to other portions of the shaft or handle assembly as will bediscussed in further detail below. In various embodiments, the elongatedshaft assembly 40 includes a spine member 50 that extends from thehandle assembly 100 to the end effector 12. The proximal end of theelongated channel 14 of the end effector 12 has a pair of retentiontrunions 17 protruding therefrom that are sized to be received withincorresponding trunion openings or cradles 52 that are provided in adistal end of the spine member 50 to enable the end effector 12 to beremovably coupled the elongated shaft assembly 40. The spine member 50may be fabricated from, for example, 6061 or 7075 aluminum, stainlesssteel, titanium, etc.

In various embodiments, the handle assembly 100 comprises a pistolgrip-type housing that may be fabricated in two or more pieces forassembly purposes. For example, the handle assembly 100 as showncomprises a right hand case member 102 and a left hand case member 104(FIGS. 5, 7, and 8) that are molded or otherwise fabricated from apolymer or plastic material and are designed to mate together. Such casemembers 102 and 104 may be attached together by snap features, pegs andsockets molded or otherwise formed therein and/or by adhesive, screws,etc. The spine member 50 has a proximal end 54 that has a flange 56formed thereon. The flange 56 is configured to be rotatably supportedwithin a groove 106 formed by mating ribs 108 that protrude inwardlyfrom each of the case members 102, 104. Such arrangement facilitates theattachment of the spine member 50 to the handle assembly 100 whileenabling the spine member 50 to be rotated relative to the handleassembly 100 about the longitudinal axis A-A in a 360° path.

As can be further seen in FIGS. 1 and 4, the spine member 50 passesthrough and is supported by a mounting bushing 60 that is rotatablyaffixed to the handle assembly 100. The mounting bushing 60 has aproximal flange 62 and a distal flange 64 that define a rotationalgroove 65 that is configured to rotatably receive a nose portion 101 ofthe handle assembly 100 therebetween. Such arrangement enables themounting bushing 60 to rotate about longitudinal axis A-A relative tothe handle assembly 100. The spine member 50 is non-rotatably pinned tothe mounting bushing 60 by a spine pin 66. In addition, a rotation knob70 is attached to the mounting bushing 60. In one embodiment, forexample, the rotation knob 70 has a hollow mounting flange portion 72that is sized to receive a portion of the mounting bushing 60 therein.In various embodiments, the rotation knob 70 may be fabricated from, forexample, glass or carbon filled Nylon, polycarbonate, Ultem®, etc. andis affixed to the mounting bushing 60 by the spine pin 66 as well. Inaddition, an inwardly protruding retention flange 74 is formed on themounting flange portion 72 and is configured to extend into a radialgroove 68 formed in the mounting bushing 60. Thus, the surgeon mayrotate the spine member 50 (and the end effector 12 attached thereto)about longitudinal axis A-A in a 360° path by grasping the rotation knob70 and rotating it relative to the handle assembly 100.

In various embodiments, the anvil 20 is retained in an open position byan anvil spring 21 or other biasing arrangement as depicted in FIGS. 1,9A, 10A, and 11A. The anvil 20 is selectively movable from the openposition to various closed or clamping and firing positions by a firingsystem, generally designated as 109. The firing system 109 includes a“firing member” 110 which, in various embodiments, comprises a hollowfiring tube 110. The hollow firing tube 110 is axially movable on thespine member 50 and thus forms the outer portion of the elongated shaftassembly 40. The firing tube 110 may be fabricated from a polymer orother suitable material and have a proximal end 112 that is attached toa firing yoke 114 of the firing system 109. See FIG. 4. In variousembodiments for example, the firing yoke 114 may be over-molded to theproximal end 112 of the firing tube 110. However, other fastenerarrangements may be employed.

As can be seen in FIGS. 1 and 4, the firing yoke 114 may be rotatablysupported within a support collar 120 that is configured to move axiallywithin the handle assembly 100. In various embodiments, the supportcollar 120 has a pair of laterally extending fins 122 that are sized tobe slidably received within fin slots 103 and 105 formed in the rightand left hand case members 102, 104, respectively. See FIG. 7. Thus, thesupport collar 120 may slide axially within the handle housing 100 whileenabling the firing yoke 114 and firing tube 110 to rotate relativethereto about the longitudinal axis A-A. As can be seen in FIG. 4, alongitudinal slot 111 is provided through the firing tube 110 to enablethe spine pin 66 to extend therethrough into the spine member 50 whilefacilitating the axial travel of the firing tube 110 on the spine member50.

The firing system 109 further comprises a firing trigger 130 whichserves to control the axial travel of the firing tube 110 on the spinemember 50. See FIG. 1. Such axial movement in the distal direction ofthe firing tube 110 into firing interaction with the anvil 20 isreferred to herein as “firing motion”. As can be seen in FIG. 1, thefiring trigger 130 is movably or pivotally coupled to the handleassembly 100 by a pivot pin 132. A torsion spring 135 is employed tobias the firing trigger 130 away from the pistol grip portion 107 of thehandle assembly 100 to an un-actuated “open” or starting position. Ascan be seen in FIGS. 1 and 4, the firing trigger 130 has an upperportion 134 that is movably attached to (pinned) firing links 136 thatare movably attached to (pinned) the support collar 120. Thus, movementof the firing trigger 130 from the starting position (FIGS. 1 and 9)toward an ending position adjacent the pistol grip portion 107 of thehandle assembly 100 (FIG. 14) will cause the firing yoke 114 and thefiring tube 110 to move in the distal direction “DD”. Movement of thefiring trigger 130 away from the pistol grip portion 107 of the handleassembly 100 (under the bias of the torsion spring 135) will cause thefiring yoke 114 and firing tube 110 to move in the proximal direction“PD” on the spine member 50.

Various embodiments of the present invention may be employed withdifferent sizes and configurations of implantable staple cartridges. Forexample, the surgical instrument 10, when used in connection with afirst firing adapter 140, may be used with a 5 mm end effector 12 thatis approximately 20 mm long (or in other lengths) which supports animplantable staple cartridge 30. Such end effector size may beparticularly well-suited, for example, to complete relatively finedissection and vascular transactions. However, as will be discussed infurther detail below, the surgical instrument 10 may also be employed,for example, in connection with other sizes of end effectors and staplecartridges by replacing the first firing adapter 140 with a secondfiring adapter 150. In still other embodiments, the elongated shaftassembly 40 may configured to be attached to only one form or size ofend effector. In such embodiments, for example, the pressure surfaces146 or 158 (normally provided on the firing adapters 140, 150,respectively) would be integrally formed in the distal end of the firingtube 110—depending upon the particular size of end effector with whichit is to be used.

As can be seen in FIG. 2, the first firing adapter 140 is substantiallyhollow and has a first spring portion 142 that is configured to extendinto an open distal end 116 of the firing tube 110. A first retainerbutton 144 is formed on the first spring portion 142 and is sized to bereceived within a retaining hole 117 provided in the distal end portionof the firing tube 110. See FIGS. 1 and 2. Thus, to detach the firstfiring adapter 140 from the firing tube 110, the user simply depressesthe retainer button 144 out of the retaining hole 117 and withdraws thefirst firing adapter 140 out of the firing tube 110. As can also be seenin FIG. 2, the first firing adapter 140 has an interior pressure surface146 that is configured to interface with the bifurcated ramp assembly 24of the anvil 20.

In various implementations, the bifurcated ramp assembly 24 on the anvil20 comprises a pair of tines 45 that are separated by a blade-receivinggroove (not shown). Each tine 45 has a proximal surface 27 that issubstantially parallel to the bottom of the elongated channel 14 whenthe anvil 20 is in a closed position. The proximal surface 27 thentransitions into a clamping ramp 28 that is distal to the proximalsurface 27. See FIG. 3. The clamping ramp 28 is oriented at a clampingangle “A” with respect to the proximal surface 27. In variousembodiments, for example, clamping angle “A” may be approximately 15 to30 degrees. As will be discussed in further detail below, when the firstpressure surface 146 of the first firing adapter 140 contacts theclamping ramp 28, the anvil 20 will be moved toward the elongatedchannel 14 and more specifically toward the staple cartridge 30 therein.As the first firing adapter 140 is further moved distally, the firstpressure surface 146 contacts a staple forming ramp 29 on each of theanvil tines 45 to further drive the anvil 20 into the staple cartridge30 to form the staples 32 therein. As is also shown in FIG. 3, thestaple forming ramp 29 is oriented at a forming angle “B” relative tothe clamping ramp 27. In various embodiments, for example, forming angle“B” may be approximately 5 to 20 degrees. The ramp assembly 24 of theanvil 20 may further have a sloped under surface 25 thereon (e.g., angle“C” is approximately 5 to 40 degrees) such that when the anvil 20 is inan open position, the sloped undersurface 25 surface enables the anvil20 to pivot to a 15° open limit (angle “n” in FIG. 11A).

One method of removably coupling the end effector 12 to the spine member50 will now be explained. The coupling process is commenced by insertingthe retention trunions 17 on the elongated channel 14 into the trunioncradles 52 in the spine member 50. Thereafter, the surgeon advances thefiring trigger 130 toward the pistol grip 107 of the housing assembly100 to distally advance the firing tube 110 and the first firing adapter140 over a proximal end portion 47 of the elongated channel 14 tothereby retain the trunions 17 in their respective cradles 52. See FIGS.10 and 10A. Such position of the first firing adapter 140 over thetrunions 17 is referred to herein as the “coupled position”. Variousembodiments of the present invention may also have an end effectorlocking assembly 160 for locking the firing trigger 130 in positionafter an end effector 12 has been attached to the spine member 50.

More specifically and with reference to FIGS. 5, 7, and 8, oneembodiment of the end effector locking assembly 160 includes a retentionpin 162 that is movably supported in the upper portion 134 of the firingtrigger 130. The retention pin 162 is spring-biased toward the left handcase member 104 by a retention spring 166. When the firing trigger 130is in an un-actuated (starting) position, the retention pin 162 isbiased into abutting contact with a start detent 163 that protrudesinwardly from the left hand case member 104. See FIGS. 7 and 8. Asdiscussed above, the firing tube 110 must initially be advanced distallyto the coupled position wherein the first firing adapter 140 retains theretention trunions 17 of the end effector 12 in the trunion cradles 52in the spine member 50. The surgeon advances the firing adapter 140distally to the coupled position by pulling the firing trigger 130 fromthe starting position toward the pistol grip 107. As the firing trigger130 is initially actuated, the retention pin 162 slides in abuttingcontact with the start detent 163 until the firing tube 110 has advancedthe first firing adapter 140 to the coupled position at which point theretention pin 162 is biased into a locking cavity 164 formed in the lefthand case member 104. See FIG. 8. In various embodiments, when theretention pin 162 enters into the locking cavity 164, the pin 162 maymake an audible “click” or other sound, as well as provide a tactileindication to the surgeon that the end effector 12 has been “locked”onto the spine member 50. In addition, the surgeon cannot inadvertentlycontinue to actuate the firing trigger 130 to start to form staples 32in the end effector 12 without intentionally biasing the retention pin162 out of the locking cavity 164. Similarly, if the surgeon releasesthe firing trigger 130 when in the coupled position, it is retained inthat position by the retention pin 162 to prevent the firing trigger 130from returning to the starting position and thereby releasing the endeffector 12 from the spine member 50.

In various implementations, a firing trigger release button 167 ismounted within the left hand case member 104 of the handle assembly 100to enable the surgeon to intentionally release the retention pin 162 toenable the firing trigger 130 to be further actuated or returned to thestarting position. See FIGS. 5, 7, and 8. The firing trigger releasebutton 167 is movably mounted within the locking cavity 164 and isspring-biased to an un-activated position (FIG. 8). When the firingtrigger release button 167 is pressed inwardly, it contacts theretention pin 162 and moves it out of the locking cavity 163 to enablethe firing trigger 130 to be further activated.

As thus far described, the surgical instrument 10 may be used as agrasping device to manipulate/position tissue. Further movement of thefiring trigger 130 toward the pistol grip portion 107 after the trigger130 has been unlocked (by depressing the retention release button 167)will cause the firing adapter 140 to contact the clamping ramp 28 on theanvil 20. As the pressure surface portion 146 of the first firingadapter rides up the clamping ramp 28, the anvil will move towards thestaple cartridge 30 in the elongated channel 14. Thus, the surgeon maymanipulate the anvil 20 toward and away from the staple cartridge 30 tograsp and release tissue therebetween without forming the staples.

Various embodiments of the present invention may further include afiring system lock button 137 that is pivotally attached to the handleassembly 100. See FIGS. 1 and 4. In one form, the firing system lockbutton 137 has a latch 138 formed on a distal end thereof that isoriented to engage the firing yoke 114 when the firing release button isin a first latching position. As can be seen in FIGS. 1 and 4, a latchspring 139 serves to bias the firing system lock button 137 to the firstlatching position (FIGS. 11 and 12). As will be explained in furtherdetail below, the latch 138 serves to engage the firing yoke 114 at apoint where the position of the firing yoke 114 on the spine member 50corresponds to a point wherein the pressure surface 146 of the firstfiring adapter 140 is about to distally advance up the clamping ramp 28on the anvil 20. It will be understood that, as the first firing adapter140 advances axially up the clamping ramp 28, the anvil 20 will move ina path such that its staple forming surface portion 22 is substantiallyparallel to the upper face 36 of the staple cartridge 30.

After the end effector 12 has been coupled to the spine member 50, thestaple forming process is commenced by first depressing the firingsystem lock button 137 to enable the firing yoke 114 to be further moveddistally on the spine member 50 and ultimately compress the anvil 20into the staple cartridge 30. See FIG. 13. After depressing the firingsystem lock button 137, the surgeon continues to actuate the firingtrigger 130 towards the pistol grip 107 thereby driving the pressuresurface 146 of the first staple collar 140 up the corresponding stapleforming ramp 29 to force the anvil 20 into forming contact with thestaples 32 in the staple cartridge 30. The firing system lock button 137prevents the inadvertent forming of the staples 32 until the surgeon isready to start that process. In this embodiment, the surgeon mustdepress the firing system lock button 137 before the firing trigger 130may be further actuated to begin the staple forming process.

The surgical instrument 10 may be solely used as a tissue staplingdevice if so desired. However, various embodiments of the presentinvention may also include a tissue cutting system, generally designatedas 170. In at least one form, the tissue cutting system 170 comprises aknife member 172 that may be selectively advanced from an un-actuatedposition adjacent the proximal end of the end effector 12 (FIGS. 1 and9-13) to an actuated position (FIG. 14) by actuating a knife advancementtrigger 200. The knife member 172 is movably supported within the spinemember 50 and is attached or otherwise protrudes from a knife rod 180.The knife member 172 may be fabricated from, for example, 420 or 440stainless steel with a hardness of greater than 38HRC (Rockwell HardnessC-scale) and have a tissue cutting edge 176 formed on the distal end 174thereof and be configured to slidably extend through a slot 31 in theanvil 20 and a centrally disposed slot 33 in the staple cartridge 30 tocut through tissue that is clamped in the end effector 12. See FIG. 14A.As can be seen in FIG. 4, the knife rod 180 extends through the spinemember 50 and has a proximal end portion 182. The proximal end portion182 drivingly interfaces with a knife transmission 190 that is operablyattached to the knife advance trigger 200. In various embodiments, theknife advance trigger 200 is attached to pivot pin 132 such that it maybe pivoted or otherwise actuated without actuating the firing trigger130. In various embodiments, a first knife gear 192 is also attached tothe pivot pin 132 such that actuation of the knife advance trigger 200also pivots the first knife gear 192. A firing return spring 202 isattached between the first knife gear 192 and the handle housing 100 tobias the knife advancement trigger 200 to a starting or un-actuatedposition. See FIGS. 1 and 4.

Turning to FIGS. 5 and 6, various embodiments of the knife transmission190 also include a second knife gear 194 that is rotatably supported ona second gear spindle 193 and in meshing engagement with the first knifegear 192. The second knife gear 194 is in meshing engagement with athird knife gear 196 that is supported on a third gear spindle 195. Alsosupported on the third gear spindle 195 is a fourth knife gear 198. Thefourth knife gear 198 is adapted to drivingly engage a series of annulargear teeth or rings 184 on a proximal end of the knife rod 180. Thus,such arrangement enables the fourth knife gear 198 to axially drive theknife rod 180 in the distal direction “DD” or proximal direction “PD”while enabling the firing rod 180 to rotate about longitudinal axis A-Awith respect to the fourth knife gear 198. Accordingly, the surgeon mayaxially advance the firing rod 180 and ultimately the knife member 172distally by pulling the knife advancement trigger 200 towards the pistolgrip 107 of the handle assembly 100.

Various embodiments of the present invention further include a knifelockout system 210 that prevents the advancement of the knife member 72unless the firing trigger 130 has been pulled to the fully firedposition (FIGS. 13 and 14). Such feature will therefore prevent theactivation of the knife advancement system 170 unless the staples havefirst been fired or formed into the tissue. As can be seen in FIG. 1,various implementations of the knife lockout system 210 comprise a knifelockout bar 211 that is pivotally supported within the pistol gripportion 107 of the handle assembly 100. The knife lockout bar 211 has anactivation end 212 that is adapted to be engaged by the firing trigger130 when the firing trigger 130 is in the fully fired position. Inaddition, the knife lockout bar 211 has a retaining hook 214 on itsother end that is adapted to hookingly engage a latch rod 216 on thefirst cut gear 192. A knife lock spring 218 is employed to bias theknife lockout bar 211 to a “locked” position wherein the retaining hook214 is retained in engagement with the latch rod 216 to thereby preventactuation of the knife advancement trigger 200 unless the firing trigger130 is in the fully fired position. See FIG. 9.

Various methods of operating at least one of the surgical instrumentembodiments of the present invention will now be explained withreference to FIGS. 9, 9A, 10, 10A, 11, 11A, 12, 12A, 13, 13A, 14, and14A. As can be appreciated from reference to FIGS. 1, 9 and 9A, when theknife bar 172 is in the depicted “starting” or un-actuated position, thetissue cutting edge 176 is proximal to the distal end of the firstfiring adapter 140 such that the sharp tissue cutting edge 176 is notexposed to the user. In alternative embodiments, wherein the elongatedshaft assembly is manufactured for use with a single form or size of endeffector (e.g., wherein the firing adapters 140, 150 are not employed),the cutting edge 176 of the knife bar 172 would be located proximal tothe distal end of the firing tube to prevent the tissue cutting edge 176from being exposed to the user in those embodiments as well.

FIGS. 9 and 9A illustrate the end effector 12 after it has been attachedto the spine member 50 by inserting the retention trunions 17 on the endeffector 12 into the trunion cradles 52 in the spine member 50. Asillustrated in FIG. 9, the firing trigger 130 is in an un-actuated orstarting position and the end effector 12 has not yet been locked to thespine member 50 by the first firing adapter 140. “P_(o)” represents thedistance that the firing trigger 130 can travel before the first firingadapter 140 starts to travel up the clamping ramp portion 28 of theanvil 20. The knife advancement trigger 200 is also in a lockedun-actuated position.

FIGS. 10 and 10A illustrate the position of the firing trigger 130 afterit has been advanced to a position wherein the end effector 12 is beenlocked to the spine member 50 by the first firing adapter 40. Thisposition is referred to herein as the “coupled” position. When in thecoupled position, the retention pin 162 has snapped into the lockingcavity 164 (FIG. 8) to thereby provide the surgeon with an audible andtactile indication that the end effector 12 is now locked to the spinemember 50. The firing trigger 130 cannot be actuated further until thesurgeon intentionally depresses the firing trigger release button 167(FIGS. 5, 7, and 8) to bias the retention pin 62 out of the lockingcavity 164. The distance that the distal end 141 of the first firingadapter 140 has traveled is represented as distance “1” (FIG. 10A) andthe corresponding distance that the firing yoke 114 has traveled on thespine member 50 is represented as distance “1”. FIGS. 11 and 11Aillustrate a position of the firing trigger 130 after the release button(not shown) has been depressed and the surgeon has activated the firingtrigger 130 to move the first firing adapter 140 to the beginning of theclamping ramps 28 on the anvil 20. As can be seen in those Figures, theanvil spring 21 has biased the anvil 20 to an open position. The travelof the distal end of the first firing adapter 140 is represented asdistance “l” and the corresponding distance that the firing yoke 114 hastraveled on the spine member 50 is represented as distance “l′₁”. FIGS.12 and 12A illustrate the position of the first firing adapter 140 afterit has been advanced to the start of the staple forming ramp 29 of theanvil 20. This position represents the maximum amount of clamping thatcan be attained before staple formation begins. This position isreferred to herein as a “maximum clamped position”. As can be seen inFIG. 12, the firing yoke 114 has contacted the latch 138 on the firingtrigger release button 137 and therefore cannot be further advanceddistally until the firing trigger release button 137 has been depressed.As can be seen in FIG. 12A, the staple forming surface 22 of the anvil20 is substantially parallel to the upper face 31 of the staplecartridge 30. The distance between the staple forming portion 22 of theanvil 20 and the top retaining surface of the elongated channel 14 hasbeen represented as “C.”. In various embodiments, C_(max) may be, forexample, 0.085 to 0.144 inches (approximately 2.15 to 3.65 mm) forstaple cartridges 30 with body portions 31 that have a substantiallyequivalent thickness. In at least one embodiment, for example, thecartridge thickness may be as much as approximately 0.01 to 0.03 inches(approximately 0.25 mm to 0.76 mm) larger than the staple size. Thetotal distance that the first firing adapter 140 has traveled from thestarting position to this maximum clamped position is represented as“l₂” and the corresponding distance that the firing yoke 114 hastraveled on the spine member 50 is represented as “l′₂”. FIGS. 13 and13A illustrate the position of the firing yoke 114 in a fully firedposition wherein the staples 32 in the staple cartridge 30 have beenfully formed. When in that position, the distance between the stapleforming portion 22 of the anvil 20 and the top retaining surface of theelongated channel 14 is represented as “C_(min).”. In variousembodiments, “C.” may be, for example, approximately 0.015 to 0.030inches (approximately 0.38 mm to 0.76 mm) for staple cartridges thatsupport staples that, when unformed, have legs that are approximately0.075 to 0.134 inches (approximately 1.90 mm to 3.40 mm) long (distance“UF” in FIG. 1A) and when fully formed have a fully formed height of,for example, approximately 0.025 inches to 0.04 inches (approximately0.63 mm to 1.01 mm) which comprises distance “FF” in FIG. 1D. The totaldistance that the first firing adapter 140 has traveled from thestarting position to this fully fired position is represented as “l₃”and the corresponding distance that the firing yoke 114 has traveled onthe spine member 50 is represented as “l′₃”. As can also be seen in FIG.13, the firing trigger 130 is in the fully fired position and hascontacted the activation end 212 of the knife lockout bar 211 to biasthe retaining hook 214 out of engagement with the latch rod 216 on thefirst cut gear 192.

Transection, especially of vessels may be one of the highest stresssteps of any surgical procedure. In the laparoscopic environment, it iseven more stressful because if something fails, the entire procedure mayneed to be converted to an open procedure almost immediately in order toprevent catastrophic events from occurring. Thus, it may be desirable toemploy a surgical stapling instrument that has the ability to optionallycut tissue after the staples have been deployed. Various embodiments ofthe present invention meet such needs.

After the staples have been “fired” (formed) into the target tissue, thesurgeon may depress the firing trigger release button 167 to enable thefiring trigger 130 to return to the starting position under the bias ofthe torsion spring 135 which enables the anvil 20 to be biased to anopen position under the bias of spring 21. When in the open position,the surgeon may withdraw the end effector 12 leaving the implantablestaple cartridge 30 and staples 32 behind. In applications wherein theend effector was inserted through a passage, working channel, etc. thesurgeon will return the anvil 20 to the closed position by activatingthe firing trigger 130 to enable the end effector 12 to be withdrawn outthrough the passage or working channel. If, however, the surgeon desiresto cut the target tissue after firing the staples, the surgeon activatesthe knife advancement trigger 200 in the above-described manner to drivethe knife bar 72 through the target tissue to the end of the endeffector as shown in FIGS. 14, 14A. FIG. 14 illustrates the amount oftravel of the knife advancement trigger 200 in various embodiments fordifferent lengths of end effectors/staple cartridges wherein the knifebar 72 has been advanced to the fully fired position within the endeffector 12. Thereafter, the surgeon may release the knife advancementtrigger 200 to enable the firing return spring 202 to cause the firingtransmission to return the knife bar 72 to the starting (un-actuated)position (FIGS. 13, 13A). Once the knife bar 72 has been returned to thestarting position, the surgeon may open the end effector jaws 13, 15 torelease the implantable cartridge 30 within the patient and thenwithdraw the end effector 12 from the patient. Thus, such surgicalinstruments of the present invention facilitate the use of smallimplantable staple cartridges that may be inserted through relativelysmaller working channels and passages, while providing the surgeon withthe option to fire the staples without cutting tissue or if desired toalso cut tissue after the staples have been fired.

As indicated above, the surgical instrument 10 can be employed inconnection with other end effectors that support other sizes of staplecartridges that contain other sizes and numbers of staples. FIGS. 15-19illustrate use of an end effector 12′ which operably supports a staplecartridge 30′ that has staples 32′ that are larger than the staples 32in the staple cartridge 30. For example, the staples 32 in a staplecartridge 30 may be approximately 0.080-0.085 inches (approximately 2.03to 2.15 mm staples, whereas the staples 32′ in the staple cartridge 30′may be approximately 0.075 inches (approximately 1.90 mm). In variousembodiments, the staple cartridge 30′ is longer than the staplecartridge 30. For example, the staple cartridge 30 may be approximately0.78 inches (approximately 20 mm) long; whereas the staple cartridge 30′may be approximately 1.57 inches (approximately 40 mm) long. FIG. 15 isan exploded view of an end effector 12′, a second firing adapter 150 andthe distal end 55 of the spine member 50. As can be seen in FIG. 15, theelongated channel 14′ has a pair of spaced side walls 16′ that each hasa slot or opening 18′ therein that is sized to receive a correspondinganvil pin 26′. The anvil 20′ and the elongated channel 14′ may togetherform an end effector 12′ that has an overall diameter that would permitthe end effector 12′ to pass through an opening that has a diameter ofat least approximately 0.20 inches (approximately 5.0 mm). The anvil 20′also has a staple forming portion 22′ that has a plurality of stapleforming pockets formed therein and a bifurcated ramp assembly 24′ thatprotrudes proximally therefrom. The proximal end 15′ of the elongatedchannel 14′ has a pair of retention trunions 17′ protruding therefromthat are sized to be received within corresponding trunion cradles 52that are provided in the spine member 50.

As can be seen in FIG. 15, the second firing adapter 150 has asubstantially hollow body portion 151 and a proximal collar portion 152that has an inwardly extending retaining protrusion 154 therein. A slot156 is provided between the body portion 151 and the proximal collarportion 152 to enable the collar portion 152 to be biased relative tothe body portion 151 to facilitate the insertion of the retainingprotrusion 154 into the retaining hole 117 in the firing tube 110. Todetach the second firing adapter 150 from the firing tube 110, thesurgeon depresses the proximal collar portion 152 to move the retainingprotrusion 154 out of the retaining hole 117 to thereby enable thesecond firing adapter 150 to be pulled distally off of the firing tube110.

In various embodiments, the anvil 20′ has a bifurcated ramp assembly 24′that comprises a pair of tines 45′ that each has a proximal surface 27′that transitions into a clamping ramp 28′ that is distal to the proximalsurface 27′. See FIG. 15. The clamping ramp 28′ is oriented at an angle“A′” with respect to the proximal surface 27′. In various embodiments,for example, angle “A′” may be approximately 50 to 30 degrees. As willbe discussed in further detail below, when a second pressure surface 158of the second firing adapter 150 contacts the clamping ramps 28′, theanvil 20′ will be moved toward the elongated channel 14′ and morespecifically toward the staple cartridge 30′ therein. See FIG. 17. Asthe second firing adapter 150 is further moved distally, the secondpressure surface 158 contacts staple forming ramps 29′ on the anviltines 45 to further drive the anvil 20′ toward the staple cartridge 30′to form the staples 32′ therein. See FIG. 18. The staple forming ramp29′ is oriented at an angle “B” relative to the clamping ramp 27′. Invarious embodiments, for example, angle “B” may be approximately 5 to 20degrees. A spring (not shown) may be provided between the ramp assembly24′ and the bottom of the elongated channel 14′ to bias the anvil 20′ tothat open position.

FIG. 16 shows the position of the second firing adapter 150 after thesurgeon has distally advanced the second firing adapter 150 to the startof the clamping ramp portions 28′. Operation of the second firingadapter 150 is controlled by the firing trigger 130 in the mannerdescribed above with respect to the first firing adapter 140. FIG. 17illustrates the position of the second firing adapter 150 in a fullyclamped position. FIG. 18 illustrates the position of the second firingadapter 150 in the fully fired position wherein the staples 32′ in thestaple cartridge 30′ have been formed through the clamped tissue (notshown).

As indicated above, the implantable staple cartridge 30′ is longer thanthe implantable staple cartridge 30. Thus, as shown in FIG. 15, the endeffector 12′ also includes a distal knife member 124 that is movablysupported in the elongated channel 14′. The distal knife member 124 hasa tissue cutting edge 125 and a proximal portion 126 that is configuredfor engagement by the knife bar 72. Thus, if the surgeon desires to cutthe tissue after the staples have been fired, the surgeon activates thefiring trigger 200 as described above to drive the knife bar 172distally into contact with the distal knife member 124 to drive thedistal knife member 124 through the tissue as illustrated in FIG. 19.The distal knife member 124 may have at least one retainer portionthereon that is adapted to slide through a correspondingly shaped slot(not shown) in the elongated channel 14′. Such arrangement enables theend effector 12′ to be opened after the staples have been formed and thetissue has been cut. The distal knife member 124 remains in the anvil20′ and is removed with the end effector 12′ when it is withdrawn fromthe patient.

Thus, various embodiments of the surgical instrument 10 have separatestapling and tissue cutting mechanisms such that the surgeon may staplethe tissue without cutting the tissue. The various embodiments of thestapling instrument of the present invention can be successfullyemployed with different sizes of end effectors that are adapted to firedifferent sizes and numbers of staples. The surgical instruments may beprovided in the form of a kit that includes an instrument 10 and a firstfiring adapter 140 and a second firing adapter 150 that enables theinstrument to be employed to fire different sizes of implantable staplecartridges.

Various unique and novel embodiments of the present invention employ acompressible staple cartridge that supports staples in a substantiallystationary position for forming contact by the anvil. Unlike priorsurgical stapling arrangements that employ staple driving elements, thestaples in the cartridges of various embodiments of the presentinvention are not driven into the anvil. In the various embodiments ofthe present invention, the anvil is driven into the unformed staples.The degree of staple formation attained is dependent upon how far theanvil is driven into the staples. Such arrangement provides the surgeonwith the ability to adjust the amount of forming or firing pressureapplied to the staples and thereby alter the final formed height of thestaples.

In various embodiments, the amount of firing motion that is applied tothe movable anvil is dependent upon the degree of actuation of thefiring trigger. For example, if the surgeon desires to attain onlypartially formed staples, then the firing trigger is only partiallydepressed inward towards the pistol grip 107. To attain more stapleformation, the surgeon simply compresses the firing trigger furtherwhich results in the anvil being further driven into forming contactwith the staples. As used herein, the term “forming contact” means thatthe staple forming surface or staple forming pockets have contacted theends of the staple legs and have started to form or bend the legs overinto a formed position. The degree of staple formation refers to how farthe staple legs have been folded over and ultimately relates to theforming height of the staple as referenced above. Those of ordinaryskill in the art will further understand that, because the anvil 20moves in a substantially parallel relationship with respect to thestaple cartridge as the firing motions are applied thereto, the staplesare formed substantially simultaneously with substantially the sameformed heights.

FIGS. 20-23 illustrate an alternative surgical instrument 10 thatemploys a staple height indicator assembly 220. In various embodiments,the staple height indicator assembly 220 comprises an indicator bar 222that is attached to the upper portion 134 of the firing trigger 130 forpivotal travel therewith. As the firing trigger 130 is pivoted towardthe pistol portion 107 of the handle assembly 100 to compress the anvil20 into the staple cartridge 30 as described above, the indicator bar222 is viewable through a window 223 in the left hand case member 104.In this embodiment, the staple height indicator assembly 220 alsoincludes a series of detents 24, 26, 28 that are formed in the left handcase member 104 and which correspond to three stages of stapleformation. In particular, once the firing trigger 130 is initiallyactuated, the retention pin 162 slides in abutting contact with thestart detent 163 until the firing tube 110 has advanced the firingadapter 140 or 150 to the above-described locking position at whichpoint the retention pin 162 is biased into a locking cavity 164 formedin the left hand case member 104. When the surgeon desires to start toclose the jaws 13, 35 of the end effector 12, the retention releasebutton 167 is depressed to enable the firing trigger 130 to be furtheractuated. When the firing trigger release button 167 is pressedinwardly, it contacts the retention pin 162 and moves it out of thelocking cavity 163 to enable the firing trigger 130 to be activated. Asdescribed above, the surgeon may now use the bottom and top jaws 13, 15,respectively of the end effector 12 to grasp and manipulate tissue. Whenthe surgeon desires to commence the staple forming process, the firingtrigger release button 167 is depressed which enables the firing yoke114 to be advanced distally as the surgeon continues to depress thefiring trigger 130.

Further advancement of the firing trigger 130 moves the anvil 20 intoforming contact with the staples 32 in the staple cartridge 30. As thefiring trigger 130 is further depressed, the flat end 165 of theretention pin 162 will slide off of starting detent 163 and contact thefirst detent 224 that corresponds to a first amount of staple formationthat is represented by a first staple height symbol 230 on the left handcase member 104. See FIG. 20. As shown, the first staple height symbol230 comprises a picture of a staple that has just started to form. Othersymbols/indicia could be used to designate this stage of stapleformation. As the retention pin 162 engages the first detent 224 andaudible click may be heard by the surgeon. The engagement of theretention pin 162 with the first detent 224 may also provide sometactile feedback to the surgeon through the firing trigger 130. Inaddition, the staple height indicator bar 222 may be viewed through theviewing window 223 adjacent to the first height staple symbol 230. Ifthe surgeon desires to further form the staples 32 in the staplecartridge, the retention pin 162 is pressed out of engagement with thefirst detent 224 by a release button 240 that is formed into the secondhand case member 104. In various embodiments for example, the releasebutton 240 may be integrally formed into the left hand case member 104with a hinge portion 242 that is part of the left hand case member 104.Such arrangement enables the release button 240 to be pressed into theend 165 of the retention pin 162 to move it out of engagement with anyof the first, second and third detents 224, 226, 228. Once the retentionpin 162 has been pressed out of the first detent 224, the firing trigger130 may be further depressed until the retention pin 162 engages thesecond staple formation detention 226. Such position of the firingtrigger 130 has resulted in further movement of the anvil 20 into stapleforming contact with the staples 32 in the staple cartridge 30. Again,the retention pin 162 snaps into the second staple formation detent 226providing the surgeon with audible and tactile feedback that the firingtrigger 130 is in the second staple formation position. When in thatposition, the staple height indicator bar 222 may be viewed through theviewing window 223 and is adjacent to the second staple height symbol232. If the surgeon desires to further form the staples 32 in the staplecartridge 30, the retention pin 162 is pressed out of engagement withthe second detent 226 by depressing the release button 240. Thereafter,the firing trigger 130 may be depressed further until the retention pin162 engages the third staple formation detent 228 corresponding to thefinal stage of staple formation. Again, the retention pin 162 snaps intothe third staple formation detent 228 providing the surgeon with audibleand tactile feedback that the firing trigger 130 is in the third stapleformation position. When in that position, the staple height indicatorbar 222 may be viewed through the viewing window 223 and is adjacent tothe staple height symbol 234. After the staples have been formed adesired amount, the surgeon may bias the retention pin 162 out of thethird staple height detent 228 to enable the firing trigger 130 toreturn to the starting position. Or, if desired, the surgeon may thencommence the tissue cutting procedure as described above beforereturning the firing trigger 130 to the starting position.

FIG. 24 illustrates an alternative embodiment wherein the staple heightindicator assembly, generally designated as 220′, does not include theseries of detents that correspond to the various staple formations. Thisembodiment, however, does include the staple height indicator bar 222and viewing window 223. Thus, the surgeon may monitor the amount ofstaple formation being achieved by monitoring the position of the stapleheight indicator bar 222 through the viewing window 223. This embodimentdoes include the staple height indicator symbols 230, 232, 234 asdescribed above. In addition, this embodiment may also include anunformed staple symbol 229 that corresponds to the starting positionwherein the staples 32 have not yet started to be formed by the anvil20. This embodiment would otherwise operate in the same mannersdescribed above.

FIGS. 25 and 26 illustrate an alternative end effector 12″ that issimilar to the end effector 12′ described above, except with thefollowing differences that are configured to accommodate a knife bar172′. The knife bar 172′ is coupled to or protrudes from a knife rod 180and is otherwise operated in the above described manner with respect tothe knife bar 172. However, in this embodiment, the knife bar 172′ islong enough to traverse the entire length of the end effector 12″ andtherefore, a separate distal knife member is not employed in the endeffector 12″. The knife bar 172′ has an upper transverse member 173′ anda lower transverse member 175′ formed thereon. The upper transversemember 173′ is oriented to slidably transverse a corresponding elongatedslot 250 in anvil 20″ and the lower transverse member 175′ is orientedto traverse an elongated slot 252 in the elongated channel 14″ of theend effector 12″. A disengagement slot (not shown) is also provide dinthe anvil 20″ such that when the knife bar 172′ has been driven to anending position with thin end effector 12″, the upper transverse member173′ drops through the corresponding slot to enable the anvil 20″ tomove to the open position to disengage the stapled and cut tissue. Theanvil 20″ may be otherwise identical to anvil 20 described above and theelongated channel 14″ may be otherwise identical to elongated channel 14described above.

In these embodiments, the anvil 20″ is biased to a fully open position(FIG. 25) by a spring or other opening arrangement (not shown). Theanvil 20″ is moved between the open and fully clamped positions by theaxial travel of the firing adapter 150 in the manner described above.Once the firing adapter 150 has been advanced to the fully clampedposition (FIG. 26), the surgeon may then advance the knife bar 172″distally in the manner described above. If the surgeon desires to usethe end effector as a grasping device to manipulate tissue, the firingadapter may be moved proximally to allow the anvil 20″ to move away fromthe elongated channel 14″ as represented in FIG. 27 in broken lines. Inthis embodiment, as the knife bar 172″ moves distally, the uppertransverse member 173′ and the lower transverse member 175′ draw theanvil 20″ and elongated channel 14″ together to achieve the desiredstaple formation as the knife bar 172″ is advanced distally through theend effector 12″. See FIG. 28. Thus, in this embodiment, stapleformation occurs simultaneously with tissue cutting, but the staplesthemselves may be sequentially formed as the knife bar 172″ is drivendistally.

FIGS. 29 and 30 illustrate use of an end effector 12″ that has an anvil20″ that is fabricated from, for example, stainless steel, titanium, PGA(Polyglycolic acid) or other absorbable plastic and is somewhatflexible. These Figures also illustrate use of a retention matrix 6250and an alignment matrix 6206 which will be discussed in further detailbelow. As can be seen in FIG. 29, the anvil 20″ flexes into the fullyformed position as the knife bar 172″ is driven distally therethrough.

In many surgical applications, it is desirable or advantageous to employa surgical cutting and stapling instrument that has an end effector thatmay be articulated relative to the elongated shaft assembly. The abilityto access tight areas with prior articulatable instruments, however, wasoften times limited due to the size and construction of the members usedto effect articulation of the end effector. FIGS. 31-40 illustrateanother surgical instrument embodiment of the present invention that iscapable of articulating the end effector relative to the elongated shaftand which employs a relatively compact articulation control arrangementin the handle assembly.

The surgical instrument 310 of this embodiment is substantially similarto the various surgical instrument embodiments 10 described above,except that this embodiment employs an articulated shaft assembly 312 tofacilitate selective positioning of the end effector 12 relative to theelongated longitudinal axis A-A. While the surgical instrument 310 willbe described herein for use in connection with an end effector 12 of thetype described above, those of ordinary skill in the art will appreciatethat the surgical instrument 310 may also be employed in connection witha second firing adapter 150 to actuate an end effector 12′ or other endeffector arrangements. As can be seen in FIGS. 31 and 32, thearticulated shaft assembly 312 includes a distal shaft assembly portion314 that is pivotally coupled to a proximal shaft assembly portion 316that is operably coupled to the handle assembly 100. In variousembodiments, for example, the distal shaft assembly 314 includes adistal spine member 320 that has a pair of trunion cradles 322 thereinfor receiving the trunions 17 therein. See FIG. 32. The distal spinemember 320 has a proximal end 324 that includes a pivot base 326 thathas a pivot pin 328 protruding therefrom.

As can be seen in FIG. 32, the proximal shaft assembly portion 316includes a proximal spine segment 330 that has a proximal pivot base andknife guide 332 attached thereto. The knife guide 332 may, for example,be welded or attached to the proximal spine segment 330 with adhesive orother fastener arrangements. A pivot hole 334 is provided in theproximal pivot base knife guide 332 to rotatably receive the pivot pin328 therein to enable the distal spine segment 320 to pivot relative tothe proximal spine segment 330 about a first pivot axis FA-FA that issubstantially transverse to the longitudinal axis A-A. The surgicalinstrument 310 further includes a distal firing tube segment 370 that ispivotally coupled to a pair of firing tube links 380, 382 for pivotaltravel about a second axis SA-SA. The distal firing tube segment 370 hasa retainer hole 372 for receiving the retainer button 144 of the firstfiring adapter 140 therein. The pair of firing tube links 380, 382 arepivotally coupled to a proximal firing tube 390 for pivotal travelrelative thereto about a third pivot axis TA-TA. See FIG. 32.

In various embodiments, the proximal firing tube 390 is attached to arotation knob 400 that is rotatably attached to the handle assembly 100.See FIGS. 31, 38 and 39. The rotation knob 400 may be molded from apolymer or plastic material and include a hub portion 402 and flangeportion 404 that is spaced from the hub portion 402. A nose portion 101of the handle assembly 100 is received between the hub portion 402 andthe flange portion 404 to enable the rotation knob 400 to be rotatablerelative to the handle assembly 100 about longitudinal axis A-A. Inother embodiments, the rotation knob 400 may be fabricated from othersuitable materials. In the depicted embodiment, the proximal firing tube390 and the proximal spine segment 330 are each non-movably attached tothe rotation knob 400. As can be seen in FIGS. 38 and 39, the proximalspine segment 330 and the proximal firing tube 390 are pinned to therotation knob 400 by a pin 406. Thus, the surgeon may rotate the endeffector 12 relative to the handle housing 100 in a 360° path about thelongitudinal axis A-A by rotating the rotation knob 400.

Referring to FIGS. 37, 38 and 40, in various embodiments, the endeffector 12 may be selectively articulated relative to the longitudinalaxis A-A by a pair of articulation members 420, 430 that are attached tothe distal pivot base 326 and an articulation ball 440 that is rotatablysupported within a socket 408 in the rotation knob 400. In variousembodiments, the articulation members 420, 430 may comprise, forexample, cables that are fabricated from multiwire cable, Nitinol,titanium, etc. The first or right articulation member 420 has a distalend 422 that has a lug 424 formed thereon that is sized to be press-fitinto a first cable attachment hole 327 that is provided in the distalpivot base 326. Likewise, the second or left articulation member 430 hasa distal end 432 that has a lug 434 formed thereon that is sized to bepress-fit into a second cable attachment hole 329 that is provided inthe distal pivot base 326. See FIG. 37. Thus, the end effector 12 may bepivoted to the right about first axis FA-FA (FIGS. 35 and 36) by pullingon the first or right articulation member 420 and the end effector 12may be pivoted to the left about first axis FA-FA by pulling the secondor left articulation member 430. In various embodiments, the rightarticulation member 420 may be slidably received within a right cablechannel 336 formed in the proximal spine segment 330 and the leftarticulation member 430 may be slidably received within a left cablechannel 338 in the proximal spine segment 330.

Turning to FIGS. 38-40, the first articulation member 420 has a proximalend 426 that has a retaining ball 428 swaged thereon or otherwiseattached thereto that is adapted to be received within a first retainingslot 442 in the articulation ball 440 that is rotatably supported withina socket 401 in the rotation knob 400. Likewise, the second articulationmember 430 has a proximal end 436 that has a retaining ball 438 swagedthereon or otherwise attached thereto that is adapted to be receivedwithin a second retaining slot 444 in the articulation ball 440. As canbe most particularly seen in FIG. 40, the articulation ball 440 furtherhas an actuator slot 446 therethrough that facilitates the unimpededpassage of the proximal firing tube segment 390 therein. As shown inFIG. 38, the actuator slot 446 may taper from wider opening portions448, 450 to a passage 452 in the center of the articulation ball 440that permits sliding passage of the proximal firing tube segment 390. Aswill be discussed further below, the articulation ball 440 is rotatablyor pivotally supported within the socket 401 and is selectively movablefrom a neutral position (shown in FIG. 38 in solid lines) to first andsecond articulation control positions (shown in FIG. 38 in brokenlines). The articulation ball 440 is also axially movable within thesocket 401.

As can be seen in FIG. 40, the surgical instrument 310 may include alocking arrangement, generally designated as 453 for locking thearticulation ball 440 in any one of the neutral, first and secondarticulation control positions. In various embodiments, the lockingarrangement 453 comprises a series of locking detent segments 454 thatare provided on the articulation ball 440 and are adapted to mate withlocking ribs 410 that are formed within a recessed 408 formed in a hubportion 402 oriented within the socket area 401 of the rotation knob400. An actuator passage 412 extends through the hub portion 402 andaligns with the actuator slot 446 in the articulation ball 440 toaccommodate the proximal firing tube segment 390 therethrough. As can beseen in FIGS. 38 and 39, an actuator ball spring 456 is journaled on aspring retention hub 414 portion of the rotation knob 400 to it bias thearticulation ball 440 proximally such that the locking detents 454 arebrought into retaining engagement with the locking ribs 410 in the hubportion 402.

To facilitate application of articulation motions to the articulationball 440, a pair of laterally extending articulation handles 458, 460protrude from the articulation ball 440 in diametrically oppositedirections. In various embodiments, the articulation ball 440 may befabricated from, for example, polycarbonate, Nylon, Ultem®, with nofill, glass fill, carbon fill, mineral fill, etc. and have the lockingdetents 454 machined or molded thereon. The articulation handles 458,460 may be attached to the articulation ball 440 by press fits, welds,etc. Such locking arrangement enables the articulation ball 440 to belocked in any of the neutral or first or second articulation positions.Once the surgeon has moved the articulation ball 440 to achieve thedesired articulated position of the end effector, the surgeon mayrelease the articulation ball 440 to enable the actuator ball spring 456to bias the articulation ball 440 proximally such that the lockingdetents 454 are brought into retaining engagement with the locking ribs410 in the hub portion 402. In various embodiments, the actuator ballspring 456 may be sized such that the articulation ball 440 may springback to the neutral position when the articulated end effector isforcibly pulled back through a trocar or similar opening. Furthermore,use of the articulation handles 458, 460 enable the degree ofarticulation to be “tuned” to the particular surgical application.

As can be seen in FIG. 38, the first or right articulation handle 458protrudes through a right slot 416 in the rotation knob 400 and thesecond or left articulation handle 460 protrudes through a left slot 418in the rotation knob 400. To articulate the end effector 12 relative tothe longitudinal axis A-A, the surgeon first moves the right and leftarticulation handles 458, 460 axially in the distal direction “DD” todisengage the locking detents 454 from the locking ribs 410 in the hubportion 402 of the rotation knob 400. Thereafter, the surgeon may pivotthe articulation ball 440 by moving the articulation handles 458, 460 inthe desired directions to apply articulation motions to the articulationmembers 420, 430. For example, the end effector 12 may be pivoted to theright by moving the right articulation handle 458 in the proximaldirection “PD” and the left articulation handle 460 in the distaldirection “DD” to apply a pulling motion (articulation motion) to theright articulation member 420 and a pushing motion to the leftarticulation member 430. Similarly, the end effector 12 may be pivotedto the left by moving the left articulation handle 460 in the proximaldirection “PD” and the right articulation handle 458 in the distaldirection “DD” to apply a pulling motion (articulation motion) to theleft articulation member 430 and a pushing motion to the rightarticulation member 420. The various ranges of motions of the right andleft articulation handles 458, 460 are illustrated in broken lines inFIG. 38. In this way, the end effector 12 can be optimally positioned ina variety of angular positions, e.g., by angling clockwise orcounterclockwise, without requiring rotation or other movement of theelongated shaft assembly 40. FIG. 35 shows the angle α which in variousembodiments can be from 0° to 45°.

Various embodiments of the surgical instrument 310 include a knife bar472 that is movably supported within the hollow proximal spine segment330 and through a knife support slot 333 that tapers from a narrowproximal portion 335 to a wide distal portion 337 to enable the knifebar 472 to flex therearound to accommodate the articulation of the endeffector 12 about the longitudinal axis A-A. See FIG. 37. In variousembodiments, the knife bar 472 may be fabricated from, for example, 300or 400 Series stainless steel and have a tissue cutting edge 476 formedon the distal end thereof. As can be further seen in FIG. 37, the knifebar 472 slidably passes through a knife slot 473 in the distal pivotbase 326. A proximal end 478 of the knife bar 472 is attached to a kniferod 480 that extends through the proximal spine segment 330 to drivinglyengage the firing transmission 190 as was described above. See FIG. 31.The retention pin 406 extends into a longitudinal slot 392 (FIG. 38) inthe proximal firing tube segment 390 and through a hole 339 in theproximal spine segment 330 (FIG. 39) and into a longitudinal slot 482 inthe knife rod 480 to enable the proximal firing tube segment 390 and theknife rod 480 to move axially relative to the proximal spine segment 330and handle assembly 100. Thus, the surgeon may selectively operate theknife bar 472 to cut tissue by operating the knife advancement trigger200 in the manner described above.

Various articulation arrangements are disclosed in U.S. patentapplication Ser. No. 12/775,809, (Attorney Docket No. END6755USNP),entitled “Laparoscopic Devices With Articulating End Effectors”, toFrederick E. Shelton IV, filed May 7, 2010 and U.S. patent applicationSer. No. 12/775,699, (Attorney Docket No. END6756USNP), entitled“Bendable Shaft For Handle Positioning” to Frederick E. Shelton IV, etal., filed May 7, 2010, the disclosures of each being hereinincorporated by reference in their respective entireties. FIGS. 41 and42 illustrate an alternative articulated shaft assembly 490 that issubstantially identical to the articulated shaft assembly 340 and isoperated in substantially the same way except for the intermediatefiring tube segment 492 which replaces the firing tube link 380 employedin the articulated shaft assembly 340. As can be seen in FIGS. 41 and42, the intermediate firing tube segment 492 extends from the distalfiring tube segment 370 to the proximal firing tube segment 390. Invarious embodiments, the intermediate firing tube segment 492 may befabricated from Nylon, Isoplast®, or other flexible plastic. In variousembodiments, the intermediate firing tube segment 492 has twolongitudinally extending compression spine portions 494 from which aplurality of spaced rib segments 496 that are separated by spaces 498extend to form a substantially hollow tube segment through which theother components of the spine assembly and knife bar may operably pass.The spine portions 494 are configured to transmit the compressionmotions from the proximal firing tube segment 390 to the distal firingtube segment 370 which are of sufficient magnitude to actuate the anvil20 to a fully fired position while enabling the end effector 12 to beselectively articulated relative to the longitudinal axis A-A. Theintermediate firing tube segment 492 has a distal end portion 491 thatis attached to the distal firing tube segment by, for example, pins,slotted bosses, snap features, etc. as well as proximal portion 493 thatis attached to the proximal firing tube segment 390 by the same orsimilar means. In this embodiment, the end effector 12 can be optimallypositioned in a variety of angular positions, e.g., by angling clockwiseor counterclockwise, without requiring rotation or other movement of theelongated shaft assembly 490. FIG. 42 shows the angle α which in variousembodiments can be from 0° to 45°.

FIGS. 43-47 illustrate another surgical instrument embodiment of thepresent invention. The surgical instrument 510 of this embodiment issubstantially similar to the surgical instrument embodiment 310described above, except for the various differences discussed below.While the surgical instrument 510 will be described herein for use inconnection with an end effector 12 of the type described above, those ofordinary skill in the art will appreciate that the surgical instrumentmay also be employed in connection with a second firing adapter 150 toactuate an end effector 12′ or it may be used in connection with otherend effector arrangements. Various embodiments of the surgicalinstrument 510 include an articulated shaft assembly 512 to facilitateselective positioning of the end effector 12 relative to thelongitudinal axis A-A. As can be seen in FIGS. 43 and 44, thearticulated shaft assembly 512 includes a distal spine member 520 thathas a pair of trunion cradles 522 therein for receiving the trunions 17therein. The distal spine member 520 has a proximal end 521 that ispivotally coupled to a distal end 531 of a proximal spine segment 530.In particular, the proximal end 521 of the distal spine segment 520 hasa pair of spaced distal spine tines 523 that support an articulation pin524 that extends through the distal end 531 of the proximal spinesegment 530 to define an articulation axis AA-AA that is substantiallytransverse to longitudinal axis A-A. See FIG. 46.

In various embodiments of the present invention, the end effector 12 isarticulatable to a variety of different orientations about thelongitudinal axis A-A. For example, angle α′ in FIG. 47 can range from180° to 90°. The end effector 12 is articulated by means of at least onearticulation member 550 that is coupled to an articulation link 540.Articulation link 540 is pivotally coupled to the distal end 521 of thedistal spine segment 520 by a distal pin 542. See FIG. 43. Thearticulation link 540 is pivotally coupled to the distal end 552 of thearticulation rod 550 by an articulation rod pin 554 as shown in FIG. 46.As can be seen in FIG. 43, the articulation member 550 extends throughthe articulated shaft assembly 512 and has a proximal end 556 thatextends into a rotation knob 560 that is rotatably coupled to the handleassembly 100. The proximal end 556 of the articulation member 550 iscoupled to an articulation control member or button 558 that is slidablycoupled to the rotation knob 560 for selective axial travel relativethereto. Thus, axially sliding the articulation button 558 in the distaldirection “DD” will cause the end effector 12 to pivot about thelongitudinal axis A-A in the manner illustrated in FIG. 47. To returnthe end effector to a starting unarticulated position wherein the endeffector is coaxially aligned on the longitudinal axis A-A, the surgeonsimply slides the actuator button 558 in the proximal direction “PD” onthe rotation knob 560.

As with some of the embodiments described above, the rotation knob 560is non-rotatably coupled to a mounting bushing 570 that is rotatablyaffixed to the handle assembly 100. See FIGS. 43 and 47. The mountingbushing 570 has a proximal flange 572 and a distal flange 574 thatdefine a rotational groove 575 therebetween to rotatably receive a noseportion 101 of the handle assembly 100 therebetween. Such arrangementenables the mounting bushing 570 to rotate about longitudinal axis A-Arelative to the handle assembly 100. The proximal spine segment 530 isnon-rotatably pinned or otherwise attached (welded, adhesive, etc.) tothe mounting bushing 570 such that rotation of the rotation knob 560about longitudinal axis A-A causes the end effector 12 to rotate aboutlongitudinal axis A-A. It will be understood that such arrangement mayfacilitate rotation of the end effector 12 in a 360° path about thelongitudinal axis A-A.

This embodiment also has a distal firing tube segment 580 that iscoupled to the first firing adapter 140 and axially movable on thedistal spine segment 520. In particular, the retainer button 144 on thefirst firing adapter 140 is received within a retainer hole 581 in thedistal firing tube segment 580 in the manner described above. The distalfiring tube segment 580 is actuated by at least one firing member thatis attached thereto. In a preferred embodiment, the distal firing tubesegment 580 is actuated by a pair of firing bands 582, 584 attachedthereto. The firing bands 582, 584 are attached to a band mount 585coupled to a proximal firing tube segment 590 that is attached to thefiring yoke 114 in the above-described manner. Also journaled on theproximal spine segment 530 and coupled to the rotation knob 560 forrotation therewith is a cover tube 592. The proximal firing tube 590 andthe band mount 585 are axially movable relative to the cover tube 592.The firing bands 582, 584 are slidably received within lateral bandchannels 526 in the distal spine member 520 as shown in FIG. 44C. Invarious embodiments, the firing bands 582, 584 each comprise a thinflexible member that may be fabricated from, for example, stainlesssteel and are each capable of pushing on the distal firing tube segment580 to actuate or close the anvil 20 in the above-described manner toform the staples 32 in the implantable staple cartridge 30. Actuation ofthe firing cables 582, 584 is accomplished by pulling the firing trigger130 in the above-described manners. Returning the firing trigger 130 tothe starting position will pull on the firing cables 582, 584 and causethe first firing adapter 140 to either pull the anvil 20 to an openposition or to move to a position wherein a spring (not shown) biasesthe anvil 20 to the open position.

The surgical instrument 510 may further include a knife 534 that ismovably supported within a knife support slot 528 in the distal spinesegment 520. See FIG. 44B. In various embodiments, the knife bar 534 maybe fabricated from, for example, 300 or 400 stainless steel, etc. andhave a tissue cutting edge 535 formed on the distal end thereof. Theknife bar 534 is attached to a knife band 536 that may be fabricatedfrom 300 or 400 series stainless steel. The knife band may, for example,comprise 0.007 to 0.012 inch thick stainless steel band material that ismore hardened than the rod. The knife cable 536 extends through thedistal spine member 520 and the proximal spine segment 530 and isattached to a knife rod 480 that drivingly engages the firingtransmission 190 as was described above. Thus, the surgeon mayselectively operate the knife bar 534 to cut tissue by operating theknife advancement trigger 200 in the manner described above. Variousembodiments may also employ a bellows-like cover member 594 to preventdirt, tissue, debris, etc. from fouling the articulation joint. See FIG.48.

FIGS. 49-53 illustrate another surgical instrument embodiment of thepresent invention. The surgical instrument 610 of this embodiment issubstantially similar to the surgical instrument embodiment 10 describedabove, except for the differences explained below. The surgicalinstrument 610 is configured to actuate an end effector 612 that has twomovable jaws 613, 615. In various embodiments, the end effector 612 iscoupled to an elongated shaft assembly 655 that protrudes from a handleassembly 100. See FIG. 49. The elongated shaft assembly 655 includes anelongated spine assembly 658 and an elongated closure tube assembly 680that is axially movable on the spine assembly 658 in the proximal anddistal directions. As shown, the elongated shaft assembly 655 extendsdistally from the handle assembly 100 in a generally straight line alonga longitudinal axis A-A. In various embodiments, the elongated shaftassembly 655 may be approximately 9 to 16 inches (approximately 228.8 mmto 406.4 mm) long. However, the elongated shaft assembly 655 may beprovided in other lengths.

Referring to FIGS. 50 and 51, in various embodiments, the lower jaw 613of the end effector 612 comprises an elongated channel 614 and the upperjaw 615 comprises an anvil 620. The elongated channel 614 has a pair ofspaced side walls 616 that each terminate in an upwardly protrudingclosure end or tip 618. The elongated channel 614 may be fabricatedfrom, for example 17-4 or 400 series stainless steel and be sized tooperably support a staple cartridge 630 or other form of staplecartridge therein. The anvil 620 may be fabricated from 416, 17-4, 17-7stainless steel, etc. In at least one embodiment, for example, endeffector 612 (when in a closed position) and the elongated shaftassembly 655 each have a maximum outer diameter that would permit thedevice to be operably passed through an opening that has a diameter ofat least approximately 8-12 mm (approximately 0.31-0.47 inches).However, the end effector 612 and elongated shaft assembly 655 may haveother diameters and shapes. The end effector 612 further includes adistal spine segment 660 that is adapted to be removably coupled to adistal end of a proximal spine segment 670 as will be further explainedbelow.

The anvil 620 has a staple forming portion 622 that has a plurality ofstaple forming pockets formed therein. In addition, the anvil 620 has abifurcated closure portion 624 that includes at least one and preferablya pair of downwardly extending closure tips 625. As can be seen in FIGS.50-53, in at least one embodiment, the closure tips 625 and thecorresponding closure ends or tips 618 of the elongated channel 614 arepivotally pinned to spine lugs 663 of a bifurcated distal end 662 of adistal spine segment 660 (FIG. 55) of a spine assembly 658 by a pivotpin 626 such that, when viewed from the side, the closure tips 625 andclosure tips 618 form a movable “scissors-like” closure structuregenerally designated as 628. In other embodiments, the anvil 620 may bemovably coupled to the elongated channel 614.

Various embodiments of the end effector 612 also include an axiallymovable knife assembly 640 that includes a knife plate 642 that has apair of spaced knife bars 644 protruding distally therefrom that areconfigured to slide axially between the spine lugs 663 of the distalspine segment 660. See FIG. 55. A knife member 646 is attached to, orotherwise formed on, the distal ends of the knife bars 644. In variousembodiments, the knife bars 644 and the knife member 646 may befabricated from, for example, 300 or 400 Series stainless steel. Atissue cutting edge 648 is formed on a distal end of the knife member646. A lower portion 649 of the knife member 646 is configured to engagea staple driving sled 650 that is movably supported within the elongatedshaft 614. The staple driving sled 650 may be retained in a slot or slotarrangements (not shown) in the elongated channel 614 to facilitateaxial movement of the staple driving sled 650 from a starting position(FIGS. 50-52) to an end position (FIG. 53) while remaining connected tothe elongated channel 614. The staple driving sled 650 has a stapledriving surface or surfaces 652 thereon that are oriented to drivinglyengage the staples 632 in the staple cartridge 630 and drive the staples632 upward toward the staple forming portion 622 of the anvil 620 as theknife member 646 is distally advanced through the end effector 612.

Also in various embodiments, a distal spine nut 668 is rotatably coupledto the proximal end 664 of the distal spine segment 660 for rotationaltravel relative thereto about the longitudinal axis A-A. The distalspine nut 668 has a pair of inwardly extending trunions 669 that aresized to be received in corresponding trunion slots 674 in a distal end672 of a proximal spine segment 670 that protrudes from the handleassembly 100 to enable the distal spine segment 660 to rotate relativeto the proximal spine segment 670. As can be seen in FIG. 49, theproximal spine segment 670 is pinned to the rotation knob 70 (by pin 66)that is rotatably mounted to the handle assembly 100 in theabove-described manner to facilitate rotation of the end effector 612about the longitudinal axis A-A in a 360° path.

As can also be seen in FIG. 49, a flange 676 is formed on a proximal end671 of the proximal spine segment 670. The flange 676 is configured tobe rotatably supported within a groove 106 formed by mating ribs 108that protrude inwardly from each of the case members 102, 104. Sucharrangement facilitates the attachment of the proximal spine segment 670to the handle assembly 100 while enabling the proximal spine segment 670to be rotated relative to the handle assembly 100 about the longitudinalaxis A-A in a 360° path. The proximal closure tube segment 682 may befabricated from a polymer or other suitable material and have a proximalend 683 that is attached to a firing yoke 114 that is constructed andmovably mounted within the handle assembly 100 in the various mannersdescribed above. In various embodiments for example, the firing yoke 114may be over-molded to the proximal end 683 of the proximal closure tubesegment 682. However, other fastener arrangements may be employed. Asdescribed above, the firing yoke 114 may be rotatably supported within asupport collar 120 that is configured to move axially within the handleassembly 100. As can be seen in FIG. 49, a longitudinal slot 681 isprovided through the proximal closure tube segment 682 to enable thespine pin 66 to extend therethrough into the proximal spine segment 670while facilitating the axial travel of the proximal closure tube segment682 on the distal spine segment 670.

As can be seen in FIG. 49, the firing trigger 130 has an upper portion134 that is pivotally (pinned) to firing links 636, 638 that arepivotally (pinned) to the support collar 120. Thus, movement of thefiring trigger 130 toward the pistol grip portion 107 of the handleassembly 100 will cause the firing yoke 114 and the proximal closuretube segment 682 to move in the proximal direction “PD” (shown in brokenlines in FIG. 49). Movement of the clamp and firing trigger 130 awayfrom the pistol grip portion 107 of the handle assembly 100 will causethe firing yoke 114 and firing tube 110 to move in the proximaldirection “DD” on the proximal spine segment 670.

As can be seen in FIGS. 50-53, the proximal closure tube segment 682 hasa distal end 684 that is configured to be attached to a proximal end 692of a distal closure tube segment 690. In the illustrated embodiment, thedistal closure tube segment 690 is configured to be threadably attachedto the distal end 684 of the proximal closure tube segment 682. Thedistal end 694 of the distal closure tube segment 690 has a tapereddrive member 696 therein that is configured to interface with thescissors-like closure structure 628 such that when the distal closuretube segment 690 is in the position illustrated in FIG. 51, an endeffector spring or springs 617 positioned between the elongated channel614 and the anvil 620 serves to bias the anvil 620 to the open positionillustrated in that Figure. However, when the distal closure tubesegment 690 is pulled in the proximal direction “PD”, the tapered drivemember 696 contacts the scissors-like closure structure 628 to pivot thejaws 613 (elongated channel 614) and 615 (anvil 620) towards each other.See FIGS. 52 and 53.

The surgical instrument 610 may further include a knife advancementsystem 639 that includes knife rod 700 that extends through the proximalspine segment 670 and has a proximal end portion 702 that drivinglyinterfaces with a firing transmission 190 that is operably attached to aknife advance trigger 200 in the manner described above. Thus, thesurgeon may advance the knife rod 700 distally by pulling the knifeadvancement trigger 200 as was described above. As can be seen in FIGS.52 and 53, the knife rod 700 has a bifurcated distal end 704 thatincludes an upper knife rod segment 706 and a lower knife rod segment708 that are configured to engage the knife plate 642. As can be seen inFIGS. 51-54, the upper knife rod segment 706 is configured to slidethrough an upper slot 773 in the spine nut 668 and the lower knife rodsegment 708 is configured to slide through a lower slot 775 in the spinenut 668.

To use the surgical instrument 610, the end effector 612 is attached tothe distal end 672 of the proximal spine segment 670 by inserting thetrunions 669 on the spine nut 668 into their corresponding trunioncradles 674 in the proximal spine segment 670. See FIG. 50. Thereafter,the surgeon or clinician may rotate the end effector 612 relative to theelongated shaft assembly 655 to thread the distal closure tube segment690 onto the proximal closure tube segment 682 to form the closure tubeassembly 680. The end effector 612 may have the staple cartridge 630therein or the clinician may install the staple cartridge into theelongated channel 614 at this or a later time. Once the end effector 612has been attached to the elongated shaft assembly 655 of the surgicalinstrument 610, the surgeon may insert the end effector 612 andelongated shaft assembly 655 through an access passage extending intothe patient (e.g., through a trocar or endoscope, etc. or through anincision—in the case of open surgery) to grasp the target tissue betweenthe end effector jaws 613, 615. As with various embodiments describedabove, the jaws 613, 615 are closed by manipulating the firing trigger130 relative to the pistol grip 107 of the handle assembly 100. Once thetarget tissue has been grasped between the end effector jaws 613, 615,the surgeon may “fire” or form the staples 632 into the target tissue bycompressing the anvil 620 into the staple cartridge 630 in the mannerdescribed above. If the procedure does not require the target tissue tobe cut, the surgeon may then release the firing trigger 130 to permitthe anvil 620 to move to the open position (under biasing motion fromspring 617) and thereby release the implantable staple cartridge 630from the end effector 612. The surgeon may then re-close the endeffector jaws 613, 615 to permit the end effector 612 to be withdrawnthrough an access passage or working channel. If, however, the surgeondesires to cut the target tissue between the lines of staples 632, thesurgeon may fire the knife assembly 640 by operating the knifeadvancement trigger 200 in the manner described above to drive the knifemember 648 distally through the target tissue. As the knife member 648moves distally through the end effector 612, it contacts the stapledriving sled 650 which serves to further drive the staples 632 intoforming contact with the staple forming surface 622 of the anvil 620 tofurther form the staples 632. See FIG. 53. Thereafter, the surgeon mayopen the end effector 612 to release the cut/staple target tissue andimplantable staple cartridge 630 therefrom.

Thus, the unique and novel closure tube arrangement which closes thejaws of the end effector by moving the closure tube distally enablessmaller closure structures to be employed while still maintaining theability to generate large closure forces required to form staples. Inaddition, this embodiment of the present invention provides the surgeonwith the flexibility to staple tissue with out cutting it inapplications not requiring the tissue to be cut.

FIGS. 56-60 illustrate an alternative surgical instrument embodiment 810that is substantially identical to the surgical instrument 610 describedabove, except for the differences discussed below. The surgicalinstrument 810, for example, includes a flexible spine assembly 820 thathas a proximal end with a flange 822 thereon that is rotatably receivedwithin a groove 106 formed by mating ribs 108 that protrude inwardlyfrom each of the case members 102, 104 forming the handle assembly 100.See FIGS. 57 and 58. Such mounting arrangement facilitates rotationaltravel of the flexible spine assembly 820 relative to the handleassembly 100. In various embodiments, the flexible spine assembly 820may be fabricated from, for example, Nylon, Acrylonitrile butadienestyrene (ABS), polycarbonate, liquid crystal polymer, stainless steel,titanium, etc. and may be configured for use with an end effector 612 ofthe type described above.

The surgical instrument 810 further includes an elongated shaft assemblygenerally represented by 830. In various embodiments, for example, theelongated shaft assembly 830 includes a reconfigurable shaft segment 840and a proximal shaft segment 844. As can be seen in FIG. 56, forexample, the reconfigurable shaft segment 840 may have a distal mountingcollar 842 that is non-movably attached to a portion of the flexiblespine assembly 820 by, for example, adhesive, welding, fasteners, etc.The reconfigurable shaft segment 840 is selectively reconfigurablebetween a linear configuration wherein all portions of thereconfigurable segment 840 are substantially coaxially aligned with eachother (i.e., they form a substantially straight hollow tubularstructure) and configurations wherein at least one of the portions isnot coaxially or linearly aligned with another portion of thereconfigurable segment 840. In the embodiment depicted in FIG. 56, forexample, the reconfigurable shaft segment 840 may be fabricated fromNylon, Acrylonitrile butadiene styrene (ABS), polycarbonate, etc. andhave a plurality of ribs 846 that facilitate the reconfiguration of thesegment 840 from a linear or coaxial alignment orientation to non-linearor non-coaxial orientations (e.g., serpentine, curved, etc.) and remainin such orientations until the user reconfigures the shaft segment 840by hand or through the use of other surgical instruments such asgrasping devices and the like. Thus, the reconfigurable shaft segment840 is “passively articulatable” meaning that the device is not equippedwith articulation means for actively controlling the articulation of thesegment 840.

In various embodiments, the proximal shaft segment 844 is coupled to thereconfigurable shaft segment 840 by, for example, interlocking featuresor pins and serves to facilitate rotational attachment of thereconfigurable shaft segment 840 to the handle assembly 100. In at leastone embodiment, for example, the proximal shaft segment 844 is coupledto the mounting bushing 60 that is rotatably affixed to the handleassembly 100 as described hereinabove. See FIGS. 57 and 59.

Also in various embodiments, a closure tube segment 832 is movablymounted on a portion of the flexible spine assembly 820 for selectivemovement thereon. See FIGS. 56 and 60. As can be seen in FIG. 60, in atleast one embodiment, the closure tube segment 832 and the spineassembly 820 are formed with opposing flanged portions 833, 821respectively, such that the closure tube segment 832 is prevented fromsliding off of the spine assembly 820 while remaining movably mountedthereon. In various embodiments, a flexible closure member 848 iscoupled to, or comprises a portion of, the firing yoke 114. See FIGS. 57and 59. The flexible closure member 848 may be fabricated from, forexample, stainless steel, etc. and have a distal end portion 849 thatextends through an elongated slot 834 in the spine assembly 820 to becoupled to the closure tube segment 832. Such arrangement facilitatesmovement of the closure tube segment 832 in the distal direction “DD”and proximal direction “PD” on the spine assembly 820 by actuating thefiring trigger 130 in the manners described above.

As can be seen in FIG. 56, the surgical instrument 810 may be employedwith an end effector 612 which was described in detail above. Inparticular, the end effector 612 may be removably coupled to theflexible spine assembly 820 by inserting the trunions 669 on the spinenut 668 into corresponding trunion slots 825 in a distal end 825 of thespine assembly 820. See FIG. 60. A distal end 835 of the closure tubesegment 832 is configured to be threadably attached to the proximal end692 of the distal closure tube segment 690 in the above-describedmanner.

In at least one embodiment, the surgical instrument 810 further includesa knife advancement system 639 that includes knife rod 700 that extendsthrough the spine assembly 820 and has a proximal end portion 702 thatdrivingly interfaces with a firing transmission 190 that is operablyattached to a knife advance trigger 200 in the manner described above.Thus, the surgeon may advance the knife rod 700 distally by pulling theknife advancement trigger 200 as was described above. The knife rod 700has a bifurcated distal end 704 that includes an upper knife rod segment706 and a lower knife rod segment 708 that are configured to engage theknife plate 642 in the end effector 612. See FIG. 60.

To use the surgical instrument 810, the end effector 612 is attached tothe distal end 823 of the spine assembly 820 by inserting the trunions669 on the spine nut 668 into their corresponding trunion cradles 825.Thereafter, the surgeon or clinician may rotate the end effector 612 tothread the distal closure tube segment 690 onto the closure tube segment832. The end effector 612 may have the staple cartridge 630 therein orthe clinician may install the staple cartridge into the elongatedchannel 614 at this time. Once the end effector 612 has been attached tothe elongated closure tube assembly 830 of the surgical instrument 810,the surgeon may configure the reconfigurable shaft segment 840 such thatthe elongated shaft assembly portions are coaxially aligned forinsertion through an opening or working channel that extends into thepatient (e.g., through a trocar or endoscope, etc. or through anincision—in the case of open surgery). Thereafter, the surgeon mayreconfigure the reconfigurable shaft segment 840 such that portionsthereof are not coaxially aligned with each other to orient the endeffector 612 attached thereto in a desired position relative to thetarget tissue. As with various embodiments described above the jaws 613,615 are closed by manipulating the firing trigger 130 relative to thepistol grip 107 of the handle assembly 100. Once the target tissue hasbeen grasped between the end effector jaws 613, 615, the surgeon may“fire” or form the staples 632 into the target tissue by compressing theanvil 620 into the staple cartridge 630 in the manner described above.If the procedure does not require the target tissue to be cut, thesurgeon may then release the firing trigger 130 to permit the anvil 620to move to the open position (under biasing motion from spring 617) andthereby release the implantable staple cartridge 630 from the endeffector 612. The surgeon may then re-close the end effector jaws 613,615 and reconfigure the reconfigurable shaft segment 840 to permit theend effector 612 to be withdrawn through an access passage or workingchannel. If, however, the surgeon desires to cut the target tissuebetween the lines of staples 632, the surgeon may fire the knifeassembly 640 by operating the knife advancement trigger 200 in themanner described above to drive the knife member 648 distally throughthe target tissue. As the knife member 648 moves distally through theend effector 612, it contacts the staple driving sled 650 which servesto further drive the staples 632 into forming contact with the stapleforming surface 622 of the anvil 620 to further form the staples 632.Thereafter, the surgeon may open the end effector 612 to release thecut/staple target tissue and implantable staple cartridge 630 therefrom.

FIGS. 61 and 62 illustrate another surgical instrument embodiment 810′that is substantially identical to the surgical instrument 810embodiment described above, except for the reconfigurable shaft segment850 which comprises a portion of an elongated shaft assembly 830′ thatis operably coupled to handle assembly 100 for operating an end effector612. In various embodiments, the reconfigurable shaft segment 850comprises a plurality of movably interconnected tubular links 852. Eachtubular link 852 may be fabricated from, for example, Nylon,Acrylonitrile butadiene styrene (ABS), polycarbonate with or withoutglass or carbon fill, etc. and have a tubular body portion 854. Thetubular body portion 854 may have a sphere-like or ball-like couplerportion 856 formed thereon that has a spine-receiving passage 858therethrough. In addition, the tubular spine-receiving passage 858extends into a hollow socket 860 formed in the tubular body portion 854that is sized to movably receive the ball-like coupler portion 856 of anadjacent tubular link 852. The ball-like coupler portions 856 are sizedrelative to the sockets 860 to permit the ball-like coupler portion 856to be snapped therein and retained in a desired configuration whereinthe shaft segment is in a substantially straight line to configurationswherein the shaft 850 may have a curved (FIG. 62) or serpentine-likeconfiguration (FIG. 61).

While the ball-like coupler portions 856 and sockets 860 may be sizedrelative to each other to create a small amount of frictional forcetherebetween that can retain the segment 850 in a desired orientationuntil an external force is applied thereto, the embodiment depicted inFIGS. 60 and 61, employs a locking system 862 to releasably retain orimmovably lock the tubular links 852 together in a desiredconfiguration. As can be seen in those Figures, the locking means 862comprises at least one, and preferably a plurality of, flexible latchnubs or members 864 formed on the perimeter of the tubular link 852adjacent one end 853 thereof. In a preferred embodiment, four latch nubs864 are employed. Other embodiments could have 1, 2, 3 or more than fourlatch nubs 864. Each tubular link 852 further comprises a locking member866 that corresponds to each latch nub 864 adjacent the other end 865 ofthe link 852. Each locking member 866 has a latch-receiving notch 868therein configured to releasably receive a portion of the correspondinglatch nub 864 formed on an adjacent tubular link 852 therein.

To use the surgical instrument 810′, the end effector 612 is attached tothe distal end 823 of the spine assembly 820 in the manner describedabove. The distal closure tube segment 690 of the end effector 612 isthreaded onto the closure tube segment 832. Once the end effector 612has been attached to the elongated closure tube assembly 830 of thesurgical instrument 810′, the surgeon may configure the reconfigurableshaft segment 850 such that the elongated shaft assembly portions arecoaxially aligned for insertion through an opening or working channelthat extends into the patient (e.g., through a trocar or endoscope, etc.or through an incision—in the case of open surgery). Thereafter, thesurgeon may employ, for example, a grasping instrument 869 to configurethe movable links 852 of the reconfigurable shaft segment 850 to adesired orientation and then press the appropriate locking nubs 864 oneach link 852 into their corresponding latch receiving notch 868 to lockthe links 852 in the desired orientation. See FIG. 62. As with variousembodiments described above, the jaws 613, 615 are closed bymanipulating the firing trigger 130 relative to the pistol grip 107 ofthe handle assembly 100. Once the target tissue has been grasped betweenthe end effector jaws 613, 615, the surgeon may “fire” or form thestaples 632 into the target tissue by compressing the anvil 620 into thestaple cartridge 630 in the manner described above. If the proceduredoes not require the target tissue to be cut, the surgeon may thenrelease the firing trigger 130 to permit the anvil 620 to move to theopen position (under biasing motion from spring 617) and thereby releasethe implantable staple cartridge 630 from the end effector 612. Thesurgeon may then re-close the end effector jaws 613, 615 and use thegrasping instrument 869 to remove the locking nubs 864 from theircorresponding latch receiving notches 868 to permit the links 852 to bealigned in such a manner to permit the device to be withdrawn through anaccess passage or working channel. If, however, the surgeon desires tocut the target tissue between the lines of staples 632, the surgeon mayfire the knife assembly 640 by operating the knife advancement trigger200 in the manner described above to drive the knife member 648 distallythrough the target tissue. As the knife member 648 moves distallythrough the end effector 612, it contacts the staple driving sled 650which serves to further drive the staples 632 into forming contact withthe staple forming surface 622 of the anvil 620 to further form thestaples 632. Thereafter, the surgeon may open the end effector 612 torelease the cut/stapled target tissue and implantable staple cartridge630 therefrom.

FIGS. 63-68 illustrate another surgical instrument embodiment 810″ thatis substantially identical to the surgical instrument embodiments 810,810′ described above, except for the reconfigurable shaft segment 870and related locking system 882 of the elongated shaft assembly. Invarious embodiments, the reconfigurable shaft segment 870 comprises aplurality of movably interconnected tubular links 872 and is coupled toa proximal shaft segment 871 that is coupled to the mounting bushing 60rotatably supported within the handle assembly 100 as discussed indetail above. Each tubular link 872 may be fabricated from, for example,Nylon, Acrylonitrile butadiene styrene (ABS), polycarbonate, etc. andhave a tubular body portion 874. See FIG. 67. The tubular body portion874 may have a sphere-like or ball-like coupler portion 876 formedthereon that has a spine-receiving passage 878 extending therethrough.In addition, the tubular spine-receiving passage 878 extends into ahollow socket 880 formed in the tubular body portion 854 that is sizedto movably receive the ball-like coupler portion 876 of an adjacenttubular link 872. The ball-like coupler portions 876 are sized relativeto the sockets 880 to permit the ball-like coupler portion 876 to besnapped therein and retained in a desired configuration wherein thereconfigurable shaft segment 870 is in a substantially straight line(FIG. 67) to configurations wherein the shaft 870 may have a curved(FIG. 68) or serpentine-like configuration.

While the ball-like coupler portions 876 and sockets 880 may be, in atleast one embodiment, sized relative to each other to create a smallamount of frictional force therebetween that can retain tubular links872 of the reconfigurable shaft segment 870 in desired orientationsuntil an external force is applied thereto, the embodiment depicted inFIGS. 63-68, employs a locking system 882 for releasably retaining orimmovably locking the tubular links 872 together in a desiredconfiguration. As can be seen in FIGS. 67 and 68, the locking means 882comprises at least one, and preferably two, selectively expandablelocking bladders 884 that extend through the tubular links 872 indiametrically opposed positions. In various embodiments, the lockingbladders 884 may be fabricated from, for example, Nylon film, etc. andbe adapted to receive pressurized fluid from a source of pressurizedfluid 886. In the embodiment depicted in FIG. 64, the source ofpressurized fluid 886 comprises fluid pump arrangement 888 that isadapted to supply air under pressure into the locking bladders 884. Inparticular, in at least one embodiment, the fluid pump arrangement 888comprises a cylinder 889 that has a piston 890 therein. The piston 890has an O-ring or other seal arrangement 891 around its perimeter and isattached to a threaded pump handle 892 that threadably engages a portionof the handle assembly 100. Thus, by screwing the pump handle 892 intothe handle assembly 100, air in the cylinder 890 is pumped underpressure through a supply conduit 893 that extends from the cylinder 890to a manifold assembly 894 that is received on the spine assembly 820.The air pressure may be relieved in the locking bladders 884 by screwingthe pump handle 894 in an opposite direction.

As can be seen in FIG. 65, the manifold assembly 894 comprises anannular manifold area 895 that is sealed on each side by O-rings orother seals 896. The annular manifold area 895 communicates with asupply line 897 that extends through the proximal shaft segment 871 andwhich is coupled for discharge into the locking bladders 884. Sucharrangement serves to supply pressurized air into the locking bladders884 while facilitating the rotational travel of the spine assembly 820about the longitudinal axis A-A relative to the handle assembly 100. Asused herein, the term pressurized fluid may comprise, for example, air,saline or preferably glycerine. In alternative embodiments, the tubularmembers may be filled with a very low durometer rubber or elastomer.When a pressure is applied to the rubber material, it will deform filingthe voids and locking the shaft in much the same way as the fluidembodiment does.

To use the surgical instrument 810″, the end effector 612 is attached tothe distal end 823 of the spine assembly 820′ in the manner describedabove. The distal closure tube segment 690 of the end effector 612 isthreaded onto the closure tube segment 832. Once the end effector 612has been attached to the elongated shaft assembly 830″ of the surgicalinstrument 810″, the surgeon may configure the reconfigurable shaftsegment 870 such that the elongated shaft assembly portions 830″ arecoaxially aligned for insertion through an opening or working channelthat extends into the patient (e.g., through a trocar or endoscope, etc.or through an incision—in the case of open surgery). Thereafter, thesurgeon may employ, for example, a grasping instrument to configure themovable links 872 of the reconfigurable shaft segment 870 to a desiredorientation. Once the reconfigurable shaft segment 870 has been orientedin a desired orientation, the surgeon may then screw in the pump handle892 into the handle housing 100 to pressurize the locking bladders 884to lock the movable links 872 in position as shown in FIG. 68. As withvarious embodiments described above, the jaws 613, 615 are closed bymanipulating the firing trigger 130 relative to the pistol grip 107 ofthe handle assembly 100. Once the target tissue has been grasped betweenthe end effector jaws 613, 615, the surgeon may “fire” or form thestaples 632 into the target tissue by compressing the anvil 620 into thestaple cartridge 630 in the manner described above. If the proceduredoes not require the target tissue to be cut, the surgeon may thenrelease the firing trigger 130 to permit the anvil 620 to move to theopen position (under biasing motion from spring 617) and thereby releasethe implantable staple cartridge 630 from the end effector 612. Thesurgeon may then re-close the end effector jaws 613, 615 and release thepressure in the locking bladders 884 by screwing the pump handle 892 inan opposite direction. A grasping instrument may be employed tomanipulate the movable links 872 to a substantially coaxially alignedorientation (FIG. 67) or other orientation required to enable the deviceto be withdrawn from the patient. If, however, the surgeon desires tocut the target tissue between the lines of staples 632, the surgeon mayfire the knife assembly 640 by operating the knife advancement trigger200 in the manner described above to drive the knife member 648 distallythrough the target tissue. As the knife member 648 moves distallythrough the end effector 612, it contacts the staple driving sled 650which serves to further drive the staples 632 into forming contact withthe staple forming surface 622 of the anvil 620 to further form thestaples 632. Thereafter, the surgeon may open the end effector 612 torelease the cut/stapled target tissue and implantable staple cartridge630 therefrom.

The various embodiments disclosed herein that include a reconfigurableshaft segment represent a vast improvement over traditionalarticulatable surgical instrument arrangements that employ lockablearticulation joints. Such surgical instruments are typically limited to1 or 2 degrees of freedom for placement of the end effector at thetransection site. The various embodiments of the present invention allowfor a wider range of possible end effector positions and thereforeprovide the surgeon with much more flexibility when using the devicethrough a single access port.

The unique and novel features of the various surgical staple cartridgesand the surgical instruments of the present invention enable the staplesin those cartridges to be arranged in one or more linear or non-linearlines. A plurality of such staple lines may be provided on each side ofan elongated slot that is centrally disposed within the staple cartridgefor receiving the tissue cutting member therethrough. In onearrangement, for example, the staples in one line may be substantiallyparallel with the staples in adjacent line(s) of staples, but offsettherefrom. In still other embodiments, one or more lines of staples maybe non-linear in nature. That is, the base of at least one staple in aline of staples may extend along an axis that is substantiallytransverse to the bases of other staples in the same staple line. Forexample, as will be discussed in further detail below, in alternativeembodiments, the lines of staples on each side of the elongated slot mayhave a zigzag appearance. Such non-linear staple arrangements may bemade possible due to the fact that the staples are not driven upwardlyinto the anvil. Instead in these various embodiments, the anvil isbrought into forming contact with the tips of the non-moving staples.Such non-linear staple arrangements may attain better tissue fasteningresults with less staples than various linear staple arrangementsemployed in prior staple cartridges wherein the staples are actuallydriven upwardly into forming contact with the anvil.

FIG. 69 illustrates use of a surgical staple cartridge embodiment 900 inan end effector embodiment 612′ of the present invention. The endeffector 612′ may be used in connection with the surgical instrument 610in the various manners described above. The end effector 612′ may beidentical to end effector 612 as described above except for thedifferences described below. As can be seen in FIGS. 69 and 70, anembodiment of the surgical staple cartridge 900 has a cartridge body 902that has a centrally disposed elongated slot 904 extending through aproximal end 903 to an area adjacent a distal end 605. The elongatedslot 904 is configured to permit knife body 646 of the surgicalinstrument 610 to axially move therethrough during a tissue cuttingoperation in the manner described above. In at least one embodiment, thecartridge body 902 consists of a compressible hemostat material such as,for example, oxidized regenerated cellulose (“ORC”) or a bio-absorbablefoam fabricated from, for example, PGA (Polyglycolic acid, sold underthe trademark Vicryl), PCL (polycaprolactone), PLA or PLLA (Polyacticacid), PDS, (Polydioxanone), PHA (polyhydroxyalkanoate), PGCL(poliglecaprone 25, sold under the trademark Monocryl) or a composite ofPGA, PCL, PLA and PDS in which lines 920, 930 of unformed staples 922are supported. However, the cartridge body 902 may be fabricated fromother materials that serve to support the unformed staples 922 in adesired orientation such that they may be compressed as the anvil 910 isbrought into contact therewith. As with various other embodimentsdescribed above, the staple cartridge 900 is implantable and is leftattached to the stapled tissue after the stapling procedure has beencompleted. In at least some embodiments, in order to prevent the staples922 from being affected and the hemostat material from being activatedduring the introduction and positioning process, the entire cartridge900 may be coated or wrapped in a biodegradable film 906 such as apolydioxanon film sold under the trademark PDS® or with a Polyglycerolsebacate (PGS) film or other biodegradable films fabricated from, forexample, PGA (Polyglycolic acid, marketed under the trade mark Vicryl),PCL (Polycaprolactone), PLA or PLLA (Polylactic acid), PHA(polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold under thetrademark Monocryl) or a composite of PGA, PCL, PLA, PDS that would beimpermeable until ruptured. The cartridge body 902 of staple cartridge900 is sized to be removably supported within the elongated channel 614of the end effector 612′.

In the embodiment depicted in FIGS. 69, 73, and 74, the surgical staplecartridge 900 operably supports a first line 920 of staples 922 on onelateral side 907 of the elongated slot 904 and a second line 930 ofstaples 922 on the other lateral side 909 of the elongated slot 904. Invarious embodiments, the staples 922 may be fabricated from a metalmaterial such as, for example, Titanium, Titanium alloys (e.g., 6AI-4VTitanium, 3al-2.5V Titanium), Stainless Steel, etc. and have a staplebase 924 and two upstanding staple legs 926 protruding therefrom. Eachstaple leg 926 may have a tissue-piercing tip 928 formed thereon. In thefirst line 920 of staples 922, the staple base 924 of at least onestaple 922 overlaps the staple base of another staple 922. In apreferred embodiment, the staple base 924 of each staple 922 overlapsthe staple bases 924 of two adjacent staples 922, except for the base924 of the last staple 922 on each end of the first staple line 920. SeeFIG. 73. Thus, the first staple line 920 has a substantially non-linearshape. More particularly, when viewed from above, the first staple line920 has a substantially zigzag appearance.

As can be seen in FIG. 72, the anvil 90 has two sequential longitudinalstaple forming pockets 912 that each has a substantial zigzag shape thatcorresponds to the shape of the first line 920 of staples 922 such that,when the anvil 910 is brought into forming contact with the staples 922,the legs 926 thereof are formed as shown in FIG. 74. Thus, the distalleg of one staple shares the same pocket as the proximal leg of the nextstaple longitudinally. Such arrangement allows for a denser pocketpattern, even to a point where the staples themselves interact (e.g.,are folded over one another). In prior staple pocket arrangements, ingeneral, there has to be between 0.005 and 0.015 inches of metal/spacefrom one set of pockets to the next. This embodiment of the presentinvention, however, has a spacing arrangement from 0 to 0.02 inches ofinterference/overlap (essentially a −0.020″) because one staple mateswith the next staple, for example. Such arrangements allow for 15-30%more staples in the same space. Furthermore, when the staples interlock,there is less need for multiple lateral rows of staples. Priorarrangements commonly employ three rows on each side of the tissue cutline to prevent the existing of an open path through which blood maypass. Lines of interlocking staples are less likely to leave pathsthrough which blood may pass. Another distinct advantage provided by thevarious interlocking staple arrangements of the present inventionrelates to improved “burst strength” which relates to the amount offorce required to tear a staple line open.

Another staple forming pocket arrangement of the present invention maycomprise a common staple forming pocket. As used herein, the term“common staple forming pocket” means that one forming pocket can formall of the staples in a single line of staples as opposed to prior anvildesigns wherein a discrete forming pocket is provided for each leg ofeach staple to be formed.

FIG. 75 illustrates yet another staple embodiment 922′ wherein the base924′ has an offset portion 928 to facilitate a tighter overlap of thebases 924′. As indicated above, the staple cartridge 900 has a secondline 930 of staples 922 supported on a second lateral side 909 of theelongated slot 904. The second line 930 of staples 922 is substantiallyidentical to the first line 920 of staples 922. Thus, the anvil 910 hasa second common staple forming pocket 912 that corresponds to the secondline of staples 930 for forming contact therewith. In alternativeembodiments, however, the second line 930 of staples 922 may differ fromthe first line 920 of staples in shape and, perhaps, number of staples.

FIG. 71 illustrates a surgical staple cartridge 900′ that issubstantially identical to the staple cartridge 900 described above,with the exception of the lines 920′, 930′ of staples 922 supportedtherein. For example, in this embodiment, the line 920′ of staples 922are arranged relative to each other such that a base axis S-S of atleast one staple base 924 is substantially transverse to the base axisS-S of the staple base 924 of at least one other adjacent staple 922.Such predetermined pattern of staples, when viewed from above, comprisesa substantially zigzag arrangement. In the embodiment depicted in FIG.76, the respective bases 924 of staples 922 may additionally have a basesupport member 927 overmolded thereon as shown. In various embodiments,the base support member 927 may be fabricated from, for example,non-absorbable plastic such as Polyether ether ketone “PEEK” orabsorbable plastic such as, for example, Polyglycolic acid “PGA”,Polylactic acid “PLA” or “PLLA”, Polydioxanone “PDS”, PCL(polycaprolactone), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25,sold under the trademark Monocryl) or various composite mixes if PGS,PDS, PLA, PGA, and PCL. The base support members 927 facilitateinterlocking between the staples without making the staples themselvesoverlap. Thus, such arrangements could form staples with “B” shapes orinverted “W” shapes without the legs of the staples themselvesoverlapping. However, the crowns are connected by the base supportmembers so they act like overlapping staples. Such arrangement allow thecombined pockets to have two discrete paths for each leg.

The embodiment depicted in FIG. 77 employs a staple line 920″ whereinthe legs 926 of adjacent staples 922 are coupled together by a couplerportion 929 molded or otherwise attached thereto. Each coupler portion929 may be fabricated from, for example, Polyether ether ketone “PEEK”or absorbable plastic such as, for example, Polyglycolic acid “PGA”,Polylactic acid “PLA” or “PLLA”, Polydioxanone “PDS”, PCL(polycaprolactone), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25,sold under the trademark Monocryl) or various composite mixes if PGS,PDS, PLA, PGA, and PCL. Such staple line 920″ has substantial zigzagappearance when viewed from above. While the various surgical staplecartridge embodiments 900, 900′ have been explained with reference touse with the end effectors 612′ and the surgical stapling instrument610, it will be understood that the staple cartridges 900, 900′ may beeffectively employed with the various other end effectors and surgicalinstruments described hereinabove, with appropriate staple formingpocket arrangements being provided in the anvils of those instruments inorder to achieved the desired amount of staple formation upon movementof the anvils into forming contact with the staples.

FIGS. 78 and 79 illustrate another surgical staple cartridge 940embodiment supported in an elongated channel 14 of a surgical instrument10 of the present invention. In at least one embodiment, the surgicalstaple cartridge 940 includes a cartridge body 942 that has a centrallydisposed elongated slot 944 extending at least partially therethrough.The elongated slot 944 is configured to permit a knife body of thesurgical instrument 10 to axially move therethrough during a tissuecutting operation in the manner described above. In various embodiments,the cartridge body 942 consists of a compressible hemostat material suchas, for example, oxidized regenerated cellulose (“ORC”) or abio-absorbable foam of the types described above or below in which lines946, 948, 950, 952 of unformed staples 922 are supported. In at leastsome embodiments, in order to prevent the staples 922 from beingaffected and the hemostat material from being activated during theintroduction and positioning process, the entire cartridge 940 may becoated or wrapped in a biodegradable film 954 such as a polydioxanonfilm sold under the trademark PDS® or with a Polyglycerol sebacate (PGS)film or other biodegradable films fabricated from, for example, PGA(Polyglycolic acid, marketed under the trade mark Vicryl), PCL(Polycaprolactone), PLA or PLLA (Polylactic acid), PHA(polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold under thetrademark Monocryl) or a composite of PGA, PCL, PLA, PDS that would beimpermeable until ruptured.

In the embodiment depicted in FIG. 78, the cartridge 940 furtherincludes a cartridge support member 960 that is coupled to the cartridgebody 942. In various embodiments, the cartridge support member 960 maybe fabricated from a rigid material such as, for example, Titanium,Stainless Steel, Aluminum, any alloy of the foregoing, etc. and may bepartially embedded within the cartridge body 942. In variousembodiments, the cartridge support member 960 may be held in place by,for example, film 954. In still other embodiments wherein a limited bondis desired, sporadic use of cyanoacylate could be used to “glue” the twocomponents together. In yet other embodiments, the cartridge body 942may be heated and “welded” or “fused” to the cartridge support member960. In various embodiments, the cartridge support member 960 forms atleast a portion of the bottom surface of the cartridge body 942 formating with the elongated channel 14. In a preferred embodiment, thecartridge support member 960 has one or more snap features 962protruding therefrom for releasably coupling the cartridge supportmember 960 to the elongated channel 14. Other forms of snapfeatures/fastener arrangements may be employed for releasably couplingthe cartridge support member 960 to the elongated channel 14.

In various embodiments, the cartridge support member 960 has a series ofsupport ridges 964, 966, 968, 970, 972, 974, 976 formed thereon toprovide some lateral support to the bases 924 of the staples 922 in thestaple lines 946, 948, 950, 952 as shown in FIG. 78. Thus, in at leastsome embodiments, the support ridges are substantially coextensive withthe staple lines.

FIG. 80 illustrates an alternative staple cartridge embodiment 940′ thatis substantially identical to cartridge 940, except for the inclusion ofupstanding fin portions 978, 979, 980, 981, 982, 983 that protrude fromthe support ridges 964, 966, 968, 970, 972, 976, respectively to provideadditional lateral support to the staples 922. In various embodiments,the fin portions may be integrally formed with the cartridge supportmember 960 and have a height that is about ½ or less of the height ofthe cartridge. Thus, in preferred embodiments, for example, any standingfeatures supporting the foam cannot extend above the maximum compressionheight of the foam. Thus, if the cartridge is designed, for example, tocompress to ⅓ of its original height when fired, the fins would between66% of the uncompressed height, all the way down to 10% of uncompressedheight.

In use, once the staples 922 have been formed through contact with theanvil 20 in the manner described above, the anvil 20 is opened and theend effector 12 is pulled away from the stapled tissue. As the endeffector 12 is pulled away from the stapled tissue, the cartridge body942 remains fastened to the stapled tissue and is then separated fromthe cartridge support member 960 which remains coupled to the elongatedchannel 14. In various embodiments, the cartridge support member 960 isprovided with a color that differs from the color of the materialcomprising the cartridge body 942 as well as the color of the elongatedchannel 14. Such arrangement provides the surgeon with an easilyrecognizable indication that no staple cartridge is present within theend effector. Thus, the surgeon will not inadvertently attempt toreinsert/use the end effector without first installing a new staplecartridge therein. To do so, the surgeon simply disconnects the snapfeatures of the cartridge support member 960 from the elongated channel14 to enable the cartridge support member 960 of a new staple cartridge940 to be placed therein. While the staple cartridges 940, 940′ havebeen explained with reference to surgical instrument 10, it will beunderstood that those cartridges may be effectively employed with manyof the other surgical instrument embodiments disclosed herein withoutdeparting from the spirit and scope of the present invention.

FIGS. 81 and 82 illustrate use of a surgical instrument embodiment 10 inconnection with an end effector 990 that is substantially identical toend effector 12 described above except for a closure lockout arrangement991 that is movably coupled to or otherwise supported within theelongated channel 14. In various embodiments, the closure lockoutarrangement 991 includes a lockout arm 992 that has a distal end 993 anda proximal end 994. The lockout arm 992 is pivotally coupled to theelongated channel about a pivot member or trunion 995. The distal endportion has a leaf spring 996 or other biasing member attached theretoto bias the lockout arm 992 into an actuated or locking position whereinthe proximal end portion 994 engages the distal end 141 of the firstfiring collar 141 to prevent the first firing collar 140 to be distallyadvanced to a “fired” position. However, when a staple cartridge 30 isinstalled in the elongated channel 14, the staple cartridge 30 causesthe lockout arm 992 to move into an unactuated or unlocked position suchthat the firing collar 140 may be advanced distally past the lockout arm992 to complete the staple firing process. See FIG. 81.

When in the locked position, the firing collar 140 cannot be advanceddistally to complete the firing process. In addition, the firing trigger130 cannot be advanced to the fully fired position wherein the knifelockout bar 210 is moved to an unlocked position to thereby enable thesurgeon to advance the knife bar 172. Thus, when there is no cartridgepresent within the end effector 990, the closure lockout arrangement 991is in the locked position which ultimately prevents the knife bar 172from being advanced. As such, the surgeon is unable to advance the knifebar 172 to cut tissue unless a cartridge 30 is present within the endeffector 990. It will be understood that the closure lockout arrangement991 as described above may be effectively incorporated into many of thesurgical instrument embodiments disclosed herein without departing fromthe spirit and scope of the present invention.

In various embodiments, a staple cartridge can comprise a cartridge bodyand a plurality of staples stored within the cartridge body. In use, thestaple cartridge can be introduced into a surgical site and positionedon a side of the tissue being treated. In addition, a staple-forminganvil can be positioned on the opposite side of the tissue. In variousembodiments, the anvil can be carried by a first jaw and the staplecartridge can be carried by a second jaw, wherein the first jaw and/orthe second jaw can be moved toward the other. Once the staple cartridgeand the anvil have been positioned relative to the tissue, the staplescan be ejected from the staple cartridge body such that the staples canpierce the tissue and contact the staple-forming anvil. Once the stapleshave been deployed from the staple cartridge body, the staple cartridgebody can then be removed from the surgical site. In various embodimentsdisclosed herein, a staple cartridge, or at least a portion of a staplecartridge, can be implanted with the staples. In at least one suchembodiment, as described in greater detail further below, a staplecartridge can comprise a cartridge body which can be compressed,crushed, and/or collapsed by the anvil when the anvil is moved from anopen position into a closed position. When the cartridge body iscompressed, crushed, and/or collapsed, the staples positioned within thecartridge body can be deformed by the anvil. Alternatively, the jawsupporting the staple cartridge can be moved toward the anvil into aclosed position. In either event, in various embodiments, the staplescan be deformed while they are at least partially positioned within thecartridge body. In certain embodiments, the staples may not be ejectedfrom the staple cartridge while, in some embodiments, the staples can beejected from the staple cartridge along with a portion of the cartridgebody.

Referring now to FIGS. 83A-83D, a compressible staple cartridge, such asstaple cartridge 1000, for example, can comprise a compressible,implantable cartridge body 1010 and, in addition, a plurality of staples1020 positioned in the compressible cartridge body 1010, although onlyone staple 1020 is depicted in FIGS. 83A-83D. FIG. 83A illustrates thestaple cartridge 1000 supported by a staple cartridge support, or staplecartridge channel, 1030, wherein the staple cartridge 1000 isillustrated in an uncompressed condition. In such an uncompressedcondition, the anvil 1040 may or may not be in contact with the tissueT. In use, the anvil 1040 can be moved from an open position intocontact with the tissue T as illustrated in FIG. 83B and position thetissue T against the cartridge body 1010. Even though the anvil 1040 canposition the tissue T against a tissue-contacting surface 1019 of staplecartridge body 1010, referring again to FIG. 83B, the staple cartridgebody 1010 may be subjected to little, if any, compressive force orpressure at such point and the staples 1020 may remain in an unformed,or unfired, condition. As illustrated in FIGS. 83A and 83B, the staplecartridge body 1010 can comprise one or more layers and the staple legs1021 of staples 1020 can extend upwardly through these layers. Invarious embodiments, the cartridge body 1010 can comprise a first layer1011, a second layer 1012, a third layer 1013, wherein the second layer1012 can be positioned intermediate the first layer 1011 and the thirdlayer 1013, and a fourth layer 1014, wherein the third layer 1013 can bepositioned intermediate the second layer 1012 and the fourth layer 1014.In at least one embodiment, the bases 1022 of the staples 1020 can bepositioned within cavities 1015 in the fourth layer 1014 and the staplelegs 1021 can extend upwardly from the bases 1022 and through the fourthlayer 1014, the third layer 1013, and the second layer 1012, forexample. In various embodiments, each deformable leg 1021 can comprise atip, such as sharp tip 1023, for example, which can be positioned in thesecond layer 1012, for example, when the staple cartridge 1000 is in anuncompressed condition. In at least one such embodiment, the tips 1023may not extend into and/or through the first layer 1011, wherein, in atleast one embodiment, the tips 1023 may not protrude through thetissue-contacting surface 1019 when the staple cartridge 1000 is in anuncompressed condition. In certain other embodiments, the sharp tips1023 may be positioned in the third layer 1013, and/or any othersuitable layer, when the staple cartridge is in an uncompressedcondition. In various alternative embodiments, a cartridge body of astaple cartridge may have any suitable number of layers such as lessthan four layers or more than four layers, for example.

In various embodiments, as described in greater detail below, the firstlayer 1011 can be comprised of a buttress material and/or plasticmaterial, such as polydioxanone (PDS) and/or polyglycolic acid (PGA),for example, and the second layer 1012 can be comprised of abioabsorbable foam material and/or a compressible hemostatic material,such as oxidized regenerated cellulose (ORC), for example. In variousembodiments, one or more of the first layer 1011, the second layer 1012,the third layer 1013, and the fourth layer 1014 may hold the staples1020 within the staple cartridge body 1010 and, in addition, maintainthe staples 1020 in alignment with one another. In various embodiments,the third layer 1013 can be comprised of a buttress material, or afairly incompressible or inelastic material, which can be configured tohold the staple legs 1021 of the staples 1020 in position relative toone another. Furthermore, the second layer 1012 and the fourth layer1014, which are positioned on opposite sides of the third layer 1013,can stabilize, or reduce the movement of, the staples 1020 even thoughthe second layer 1012 and the fourth layer 1014 can be comprised of acompressible foam or elastic material. In certain embodiments, thestaple tips 1023 of the staple legs 1021 can be at least partiallyembedded in the first layer 1011. In at least one such embodiment, thefirst layer 1011 and the third layer 1013 can be configured toco-operatively and firmly hold the staple legs 1021 in position. In atleast one embodiment, the first layer 1011 and the third layer 1013 caneach be comprised of a sheet of bioabsorbable plastic, such aspolyglycolic acid (PGA) which is marketed under the trade name Vicryl,polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate(PHA), poliglecaprone 25 (PGCL) which is marketed under the trade nameMonocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS,PHA, PGCL and/or PCL, for example, and the second layer 1012 and thefourth layer 1014 can each be comprised of at least one hemostaticmaterial or agent.

Although the first layer 1011 can be compressible, the second layer 1012can be substantially more compressible than the first layer 1011. Forexample, the second layer 1012 can be about twice as compressible, aboutthree times as compressible, about four times as compressible, aboutfive times as compressible, and/or about ten times as compressible, forexample, as the first layer 1011. Stated another way, the second layer1012 may compress about two times, about three times, about four times,about five times, and/or about ten times as much as first layer 1011,for a given force. In certain embodiments, the second layer 1012 can bebetween about twice as compressible and about ten times as compressible,for example, as the first layer 1011. In at least one embodiment, thesecond layer 1012 can comprise a plurality of air voids defined therein,wherein the amount and/or size of the air voids in the second layer 1012can be controlled in order to provide a desired compressibility of thesecond layer 1012. Similar to the above, although the third layer 1013can be compressible, the fourth layer 1014 can be substantially morecompressible than the third layer 1013. For example, the fourth layer1014 can be about twice as compressible, about three times ascompressible, about four times as compressible, about five times ascompressible, and/or about ten times as compressible, for example, asthe third layer 1013. Stated another way, the fourth layer 1014 maycompress about two times, about three times, about four times, aboutfive times, and/or about ten times as much as third layer 1013, for agiven force. In certain embodiments, the fourth layer 1014 can bebetween about twice as compressible and about ten times as compressible,for example, as the third layer 1013. In at least one embodiment, thefourth layer 1014 can comprise a plurality of air voids defined therein,wherein the amount and/or size of the air voids in the fourth layer 1014can be controlled in order to provide a desired compressibility of thefourth layer 1014. In various circumstances, the compressibility of acartridge body, or cartridge body layer, can be expressed in terms of acompression rate, i.e., a distance in which a layer is compressed for agiven amount of force. For example, a layer having a high compressionrate will compress a larger distance for a given amount of compressiveforce applied to the layer as compared to a layer having a lowercompression rate. This being said, the second layer 1012 can have ahigher compression rate than the first layer 1011 and, similarly, thefourth layer 1014 can have a higher compression rate than the thirdlayer 1013. In various embodiments, the second layer 1012 and the fourthlayer 1014 can be comprised of the same material and can comprise thesame compression rate. In various embodiments, the second layer 1012 andthe fourth layer 1014 can be comprised of materials having differentcompression rates. Similarly, the first layer 1011 and the third layer1013 can be comprised of the same material and can comprise the samecompression rate. In certain embodiments, the first layer 1011 and thethird layer 1013 can be comprised of materials having differentcompression rates.

As the anvil 1040 is moved toward its closed position, the anvil 1040can contact tissue T and apply a compressive force to the tissue T andthe staple cartridge 1000, as illustrated in FIG. 83C. In suchcircumstances, the anvil 1040 can push the top surface, ortissue-contacting surface 1019, of the cartridge body 1010 downwardlytoward the staple cartridge support 1030. In various embodiments, thestaple cartridge support 1030 can comprise a cartridge support surface1031 which can be configured to support the staple cartridge 1000 as thestaple cartridge 1000 is compressed between the cartridge supportsurface 1031 and the tissue-contacting surface 1041 of anvil 1040. Owingto the pressure applied by the anvil 1040, the cartridge body 1010 canbe compressed and the anvil 1040 can come into contact with the staples1020. More particularly, in various embodiments, the compression of thecartridge body 1010 and the downward movement of the tissue-contactingsurface 1019 can cause the tips 1023 of the staple legs 1021 to piercethe first layer 1011 of cartridge body 1010, pierce the tissue T, andenter into forming pockets 1042 in the anvil 1040. As the cartridge body1010 is further compressed by the anvil 1040, the tips 1023 can contactthe walls defining the forming pockets 1042 and, as a result, the legs1021 can be deformed or curled inwardly, for example, as illustrated inFIG. 83C. As the staple legs 1021 are being deformed, as alsoillustrated in FIG. 83C, the bases 1022 of the staples 1020 can be incontact with or supported by the staple cartridge support 1030. Invarious embodiments, as described in greater detail below, the staplecartridge support 1030 can comprise a plurality of support features,such as staple support grooves, slots, or troughs 1032, for example,which can be configured to support the staples 1020, or at least thebases 1022 of the staples 1020, as the staples 1020 are being deformed.As also illustrated in FIG. 83C, the cavities 1015 in the fourth layer1014 can collapse as a result of the compressive force applied to thestaple cartridge body 1010. In addition to the cavities 1015, the staplecartridge body 1010 can further comprise one or more voids, such asvoids 1016, for example, which may or may not comprise a portion of astaple positioned therein, that can be configured to allow the cartridgebody 1010 to collapse. In various embodiments, the cavities 1015 and/orthe voids 1016 can be configured to collapse such that the wallsdefining the cavities and/or walls deflect downwardly and contact thecartridge support surface 1031 and/or contact a layer of the cartridgebody 1010 positioned underneath the cavities and/or voids.

Upon comparing FIG. 83B and FIG. 83C, it is evident that the secondlayer 1012 and the fourth layer 1014 have been substantially compressedby the compressive pressure applied by the anvil 1040. It may also benoted that the first layer 1011 and the third layer 1013 have beencompressed as well. As the anvil 1040 is moved into its closed position,the anvil 1040 may continue to further compress the cartridge body 1010by pushing the tissue-contacting surface 1019 downwardly toward thestaple cartridge support 1030. As the cartridge body 1010 is furthercompressed, the anvil 1040 can deform the staples 1020 into theircompletely-formed shape as illustrated in FIG. 83D. Referring to FIG.83D, the legs 1021 of each staple 1020 can be deformed downwardly towardthe base 1022 of each staple 1020 in order to capture at least a portionof the tissue T, the first layer 1011, the second layer 1012, the thirdlayer 1013, and the fourth layer 1014 between the deformable legs 1021and the base 1022. Upon comparing FIGS. 83C and 83D, it is furtherevident that the second layer 1012 and the fourth layer 1014 have beenfurther substantially compressed by the compressive pressure applied bythe anvil 1040. It may also be noted upon comparing FIGS. 83C and 83Dthat the first layer 1011 and the third layer 1013 have been furthercompressed as well. After the staples 1020 have been completely, or atleast sufficiently, formed, the anvil 1040 can be lifted away from thetissue T and the staple cartridge support 1030 can be moved away, and/ordetached from, the staple cartridge 1000. As depicted in FIG. 83D, andas a result of the above, the cartridge body 1010 can be implanted withthe staples 1020. In various circumstances, the implanted cartridge body1010 can support the tissue along the staple line. In somecircumstances, a hemostatic agent, and/or any other suitable therapeuticmedicament, contained within the implanted cartridge body 1010 can treatthe tissue over time. A hemostatic agent, as mentioned above, can reducethe bleeding of the stapled and/or incised tissue while a bonding agentor tissue adhesive can provide strength to the tissue over time. Theimplanted cartridge body 1010 can be comprised of materials such as ORC(oxidized regenerated cellulous), protein matrix, polyglycolic acid(PGA) which is marketed under the trade name Vicryl, polylactic acid(PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA),poliglecaprone 25 (PGCL) which is marketed under the trade nameMonocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS,PHA, PGCL and/or PCL, for example. In certain circumstances, thecartridge body 1010 can comprise an antibiotic and/or anti-microbialmaterial, such as colloidal silver and/or triclosan, for example, whichcan reduce the possibility of infection in the surgical site.

In various embodiments, the layers of the cartridge body 1010 can beconnected to one another. In at least one embodiment, the second layer1012 can be adhered to the first layer 1011, the third layer 1013 can beadhered to the second layer 1012, and the fourth layer 1014 can beadhered to the third layer 1013 utilizing at least one adhesive, such asfibrin and/or protein hydrogel, for example. In certain embodiments,although not illustrated, the layers of the cartridge body 1010 can beconnected together by interlocking mechanical features. In at least onesuch embodiment, the first layer 1011 and the second layer 1012 can eachcomprise corresponding interlocking features, such as a tongue andgroove arrangement and/or a dovetail joint arrangement, for example.Similarly, the second layer 1012 and the third layer 1013 can eachcomprise corresponding interlocking features while the third layer 1013and the fourth layer 1014 can each comprise corresponding interlockingfeatures. In certain embodiments, although not illustrated, the staplecartridge 1000 can comprise one or more rivets, for example, which canextend through one or more layers of the cartridge body 1010. In atleast one such embodiment, each rivet can comprise a first end, or head,positioned adjacent to the first layer 1011 and a second head positionedadjacent to the fourth layer 1014 which can be either assembled to orformed by a second end of the rivet. Owing to the compressible nature ofthe cartridge body 1010, in at least one embodiment, the rivets cancompress the cartridge body 1010 such that the heads of the rivets canbe recessed relative to the tissue-contacting surface 1019 and/or thebottom surface 1018 of the cartridge body 1010, for example. In at leastone such embodiment, the rivets can be comprised of a bioabsorbablematerial, such as polyglycolic acid (PGA) which is marketed under thetrade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS),polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketedunder the trade name Monocryl, polycaprolactone (PCL), and/or acomposite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example. Incertain embodiments, the layers of the cartridge body 1010 may not beconnected to one another other than by the staples 1020 containedtherein. In at least one such embodiment, the frictional engagementbetween the staple legs 1021 and the cartridge body 1010, for example,can hold the layers of the cartridge body 1010 together and, once thestaples have been formed, the layers can be captured within the staples1020. In certain embodiments, at least a portion of the staple legs 1021can comprise a roughened surface or rough coating which can increase thefriction forces between the staples 1020 and the cartridge body 1010.

As described above, a surgical instrument can comprise a first jawincluding the staple cartridge support 1030 and a second jaw includingthe anvil 1040. In various embodiments, as described in greater detailfurther below, the staple cartridge 1000 can comprise one or moreretention features which can be configured to engage the staplecartridge support 1030 and, as a result, releasably retain the staplecartridge 1000 to the staple cartridge support 1030. In certainembodiments, the staple cartridge 1000 can be adhered to the staplecartridge support 1030 by at least one adhesive, such as fibrin and/orprotein hydrogel, for example. In use, in at least one circumstance,especially in laparoscopic and/or endoscopic surgery, the second jaw canbe moved into a closed position opposite the first jaw, for example,such that the first and second jaws can be inserted through a trocarinto a surgical site. In at least one such embodiment, the trocar candefine an approximately 5 mm aperture, or cannula, through which thefirst and second jaws can be inserted. In certain embodiments, thesecond jaw can be moved into a partially-closed position intermediatethe open position and the closed position which can allow the first andsecond jaws to be inserted through the trocar without deforming thestaples 1020 contained in the staple cartridge body 1010. In at leastone such embodiment, the anvil 1040 may not apply a compressive force tothe staple cartridge body 1010 when the second jaw is in itspartially-closed intermediate position while, in certain otherembodiments, the anvil 1040 can compress the staple cartridge body 1010when the second jaw is in its partially-closed intermediate position.Even though the anvil 1040 can compress the staple cartridge body 1010when it is in such an intermediate position, the anvil 1040 may notsufficiently compress the staple cartridge body 1010 such that the anvil1040 comes into contact with the staples 1020 and/or such that thestaples 1020 are deformed by the anvil 1040. Once the first and secondjaws have been inserted through the trocar into the surgical site, thesecond jaw can be opened once again and the anvil 1040 and the staplecartridge 1000 can be positioned relative to the targeted tissue asdescribed above.

In various embodiments, referring now to FIGS. 84A-84D, an end effectorof a surgical stapler can comprise an implantable staple cartridge 1100positioned intermediate an anvil 1140 and a staple cartridge support1130. Similar to the above, the anvil 1140 can comprise atissue-contacting surface 1141, the staple cartridge 1100 can comprise atissue-contacting surface 1119, and the staple cartridge support 1130can comprise a support surface 1131 which can be configured to supportthe staple cartridge 1100. Referring to FIG. 84A, the anvil 1140 can beutilized to position the tissue T against the tissue contacting surface1119 of staple cartridge 1100 without deforming the staple cartridge1100 and, when the anvil 1140 is in such a position, thetissue-contacting surface 1141 can be positioned a distance 1101 a awayfrom the staple cartridge support surface 1131 and the tissue-contactingsurface 1119 can be positioned a distance 1102 a away from the staplecartridge support surface 1131. Thereafter, as the anvil 1140 is movedtoward the staple cartridge support 1130, referring now to FIG. 84B, theanvil 1140 can push the top surface, or tissue-contacting surface 1119,of staple cartridge 1100 downwardly and compress the first layer 1111and the second layer 1112 of cartridge body 1110. As the layers 1111 and1112 are compressed, referring again to FIG. 84B, the second layer 1112can be crushed and the legs 1121 of staples 1120 can pierce the firstlayer 1111 and enter into the tissue T. In at least one such embodiment,the staples 1120 can be at least partially positioned within staplecavities, or voids, 1115 in the second layer 1112 and, when the secondlayer 1112 is compressed, the staple cavities 1115 can collapse and, asa result, allow the second layer 1112 to collapse around the staples1120. In various embodiments, the second layer 1112 can comprise coverportions 1116 which can extend over the staple cavities 1115 andenclose, or at least partially enclose, the staple cavities 1115. FIG.84B illustrates the cover portions 1116 being crushed downwardly intothe staple cavities 1115. In certain embodiments, the second layer 1112can comprise one or more weakened portions which can facilitate thecollapse of the second layer 1112. In various embodiments, such weakenedportions can comprise score marks, perforations, and/or thincross-sections, for example, which can facilitate a controlled collapseof the cartridge body 1110. In at least one embodiment, the first layer1111 can comprise one or more weakened portions which can facilitate thepenetration of the staple legs 1121 through the first layer 1111. Invarious embodiments, such weakened portions can comprise score marks,perforations, and/or thin cross-sections, for example, which can bealigned, or at least substantially aligned, with the staple legs 1121.

When the anvil 1140 is in a partially closed, unfired position,referring again to FIG. 84A, the anvil 1140 can be positioned a distance1101 a away from the cartridge support surface 1131 such that a gap isdefined therebetween. This gap can be filled by the staple cartridge1100, having a staple cartridge height 1102 a, and the tissue T. As theanvil 1140 is moved downwardly to compress the staple cartridge 1100,referring again to FIG. 84B, the distance between the tissue contactingsurface 1141 and the cartridge support surface 1131 can be defined by adistance 1101 b which is shorter than the distance 1101 a. In variouscircumstances, the gap between the tissue-contacting surface 1141 ofanvil 1140 and the cartridge support surface 1131, defined by distance1101 b, may be larger than the original, undeformed staple cartridgeheight 1102 a. As the anvil 1140 is moved closer to the cartridgesupport surface 1131, referring now to FIG. 84C, the second layer 1112can continue to collapse and the distance between the staple legs 1121and the forming pockets 1142 can decrease. Similarly, the distancebetween the tissue-contacting surface 1141 and the cartridge supportsurface 1131 can decrease to a distance 1101 c which, in variousembodiments, may be greater than, equal to, or less than the original,undeformed cartridge height 1102 a. Referring now to FIG. 84D, the anvil1140 can be moved into a final, fired position in which the staples 1120have been fully formed, or at least formed to a desired height. In sucha position, the tissue-contacting surface 1141 of anvil 1140 can be adistance 1101 d away from the cartridge support surface 1131, whereinthe distance 1101 d can be shorter than the original, undeformedcartridge height 1102 a. As also illustrated in FIG. 84D, the staplecavities 1115 may be fully, or at least substantially, collapsed and thestaples 1120 may be completely, or at least substantially, surrounded bythe collapsed second layer 1112. In various circumstances, the anvil1140 can be thereafter moved away from the staple cartridge 1100. Oncethe anvil 1140 has been disengaged from the staple cartridge 1100, thecartridge body 1110 can at least partially re-expand in variouslocations, i.e., locations intermediate adjacent staples 1120, forexample. In at least one embodiment, the crushed cartridge body 1110 maynot resiliently re-expand. In various embodiments, the formed staples1120 and, in addition, the cartridge body 1110 positioned intermediateadjacent staples 1120 may apply pressure, or compressive forces, to thetissue T which may provide various therapeutic benefits.

As discussed above, referring again to the embodiment illustrated inFIG. 84A, each staple 1120 can comprise staple legs 1121 extendingtherefrom. Although staples 1120 are depicted as comprising two staplelegs 1121, various staples can be utilized which can comprise one stapleleg or, alternatively, more than two staple legs, such as three staplelegs or four staple legs, for example. As illustrated in FIG. 84A, eachstaple leg 1121 can be embedded in the second layer 1112 of thecartridge body 1110 such that the staples 1120 are secured within thesecond layer 1112. In various embodiments, the staples 1120 can beinserted into the staple cavities 1115 in cartridge body 1110 such thatthe tips 1123 of the staple legs 1121 enter into the cavities 1115before the bases 1122. After the tips 1123 have been inserted into thecavities 1115, in various embodiments, the tips 1123 can be pressed intothe cover portions 1116 and incise the second layer 1112. In variousembodiments, the staples 1120 can be seated to a sufficient depth withinthe second layer 1112 such that the staples 1120 do not move, or atleast substantially move, relative to the second layer 1112. In certainembodiments, the staples 1120 can be seated to a sufficient depth withinthe second layer 1112 such that the bases 1122 are positioned orembedded within the staple cavities 1115. In various other embodiments,the bases 1122 may not be positioned or embedded within the second layer1112. In certain embodiments, referring again to FIG. 84A, the bases1122 may extend below the bottom surface 1118 of the cartridge body1110. In certain embodiments, the bases 1122 can rest on, or can bedirectly positioned against, the cartridge support surface 1130. Invarious embodiments, the cartridge support surface 1130 can comprisesupport features extending therefrom and/or defined therein wherein, inat least one such embodiment, the bases 1122 of the staples 1120 may bepositioned within and supported by one or more support grooves, slots,or troughs, 1132, for example, in the staple cartridge support 1130, asdescribed in greater detail further below.

Further to the above, referring now to FIG. 85, the bases 1122 of thestaples 1120 can be positioned directly against the support surface 1131of staple cartridge support 1130. In various embodiments, includingembodiments where the staple bases 1122 comprise circular or arcuatebottom surfaces 1124, for example, the staple bases 1122 may move orslide along the staple cartridge support surface 1131. Such sliding canoccur when the anvil 1140 is pressed against the tips 1123 of the staplelegs 1121 during the staple forming process. In certain embodiments, asdescribed above and referring now to FIG. 86, the staple cartridgesupport 1130 can comprise one or more support slots 1132 therein whichcan be configured to eliminate, or at least reduce, the relativemovement between the staple bases 1122 and the cartridge support surface1131. In at least one such embodiment, each support slot 1132 can bedefined by a surface contour which matches, or at least substantiallymatches, the contour of the bottom surface of the staple positionedtherein. For example, the bottom surface 1124 of the base 1122 depictedin FIG. 86 can comprise a circular, or at least substantially circular,surface and the support slot 1132 can also comprise a circular, or atleast substantially circular, surface. In at least one such embodiment,the surface defining the slot 1132 can be defined by a radius ofcurvature which is greater than or equal to a radius of curvature whichdefines bottom surface 1124. Although the slots 1132 may assist inpreventing or reducing relative sliding movement between the staples1120 and the staple cartridge support 1130, the slots 1132 may also beconfigured to prevent or reduce relative rotational movement between thestaples 1120 and the staple cartridge support 1130. More particularly,in at least one embodiment, the slots 1132 can be configured to closelyreceive the bases 1122 in order to prevent or reduce the rotation of thestaples 1120 about axes 1129, for example, such that the staples 1120 donot rotate or twist when they are being deformed.

In various embodiments, further to the above, each staple 1120 can beformed from a round, or an at least substantially round, wire. Incertain embodiments, the legs and the base of each staple can be formedfrom a wire having a non-circular cross-section, such as a rectangularcross-section, for example. In at least one such embodiment, the staplecartridge support 1130 can comprise corresponding non-circular slots,such as rectangular slots, for example, configured to receive the basesof such staples. In various embodiments, referring now to FIG. 87, eachstaple 1120 can comprise a crown, such as a crown 1125, for example,overmolded onto a base 1122 wherein each crown 1125 can be positionedwithin a support slot in the staple cartridge support 1130. In at leastone such embodiment, each crown 1125 can comprise a square and/orrectangular cross-section, for example, which can be configured to bereceived within square and/or rectangular slots 1134, for example, inthe staple cartridge support 1130. In various embodiments, the crowns1125 can be comprised of a bioabsorbable plastic, such as polyglycolicacid (PGA) which is marketed under the trade name Vicryl, polylacticacid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA),poliglecaprone 25 (PGCL) which is marketed under the trade nameMonocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS,PHA, PGCL and/or PCL, for example, and can be formed around the bases1122 of the staples 1120 by an injection molding process, for example.Various crowns and methods for forming various crowns are disclosed inU.S. patent application Ser. No. 11/541,123, entitled SURGICAL STAPLESHAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN ANDSTAPLING INSTRUMENTS FOR DEPLOYING THE SAME, filed on Sep. 29, 2006, theentire disclosure of which is incorporated be reference herein.Referring again to FIG. 87, the slots 1134 can further compriselead-ins, or bevels, 1135 which can be configured to facilitate theinsertion of the crowns 1125 into the slots 1134. In variousembodiments, the bases and/or crowns of the staples 1120 may bepositioned within the slots 1134 when the staple cartridge 1100 isassembled to the staple cartridge support 1130. In certain embodiments,the crowns 1125 of the staples 1120 may be aligned with the slots 1134when the staple cartridge 1100 is assembled to the staple cartridgesupport 1130. In at least one such embodiment, the crowns 1125 may notenter into the slots 1134 until a compressive force is applied to thestaple legs 1121 and the bases and/or crowns of the staples 1120 arepushed downwardly into the slots 1134.

In various embodiments, referring now to FIGS. 88 and 89, a staplecartridge, such as staple cartridge 1200, for example, can comprise acompressible, implantable cartridge body 1210 comprising an outer layer1211 and an inner layer 1212. Similar to the above, the staple cartridge1200 can comprise a plurality of staples 1220 positioned within thecartridge body 1210. In various embodiments, each staple 1220 cancomprise a base 1222 and one or more staple legs 1221 extendingtherefrom. In at least one such embodiment, the staple legs 1221 can beinserted into the inner layer 1212 and seated to a depth in which thebases 1222 of the staples 1220 abut and/or are positioned adjacent tothe bottom surface 1218 of the inner layer 1212, for example. In theembodiment depicted in FIGS. 88 and 89, the inner layer 1212 does notcomprise staple cavities configured to receive a portion of the staples1220 while, in other embodiments, the inner layer 1212 can comprise suchstaple cavities. In various embodiments, further to the above, the innerlayer 1212 can be comprised of a compressible material, such asbioabsorbable foam and/or oxidized regenerated cellulose (ORC), forexample, which can be configured to allow the cartridge body 1210 tocollapse when a compressive load is applied thereto. In variousembodiments, the inner layer 1212 can be comprised of a lyophilized foamcomprising polylactic acid (PLA) and/or polyglycolic acid (PGA), forexample. The ORC may be commercially available under the trade nameSurgicel and can comprise a loose woven fabric (like a surgical sponge),loose fibers (like a cotton ball), and/or a foam. In at least oneembodiment, the inner layer 1212 can be comprised of a materialincluding medicaments, such as freeze-dried thrombin and/or fibrin, forexample, contained therein and/or coated thereon which can bewater-activated and/or activated by fluids within the patient's body,for example. In at least one such embodiment, the freeze-dried thrombinand/or fibrin can be held on a Vicryl (PGA) matrix, for example. Incertain circumstances, however, the activatable medicaments can beunintentionally activated when the staple cartridge 1200 is insertedinto a surgical site within the patient, for example. In variousembodiments, referring again to FIGS. 88 and 89, the outer layer 1211can be comprised of a water impermeable, or at least substantially waterimpermeable, material such that liquids do not come into contact with,or at least substantially contact, the inner layer 1212 until after thecartridge body 1210 has been compressed and the staple legs havepenetrated the outer layer 1211 and/or after the outer layer 1211 hasbeen incised in some fashion. In various embodiments, the outer layer1211 can be comprised of a buttress material and/or plastic material,such as polydioxanone (PDS) and/or polyglycolic acid (PGA), for example.In certain embodiments, the outer layer 1211 can comprise a wrap whichsurrounds the inner layer 1212 and the staples 1220. More particularly,in at least one embodiment, the staples 1220 can be inserted into theinner layer 1212 and the outer layer 1211 can be wrapped around thesub-assembly comprising the inner layer 1212 and the staples 1220 andthen sealed.

In various embodiments, referring now to FIGS. 90 and 91, a staplecartridge, such as staple cartridge 1300, for example, can comprise acompressible, implantable cartridge body 1310 including an outer layer1311 and an inner layer 1312. Similar to the above, the staple cartridge1300 can further comprise staples 1320 positioned within the cartridgebody 1310 wherein each staple 1320 can comprise a base 1322 and one ormore legs 1321 extending therefrom. Similar to staple cartridge 1200,the bases 1322 of staples 1320 can extend below the bottom surface 1318of the inner layer 1312 and the outer layer 1311 can surround the bases1322. In at least one such embodiment, the outer layer 1311 can besufficiently flexible so as to envelop each staple base 1322 such thatthe outer layer 1311 conforms to the contour of the bases 1322. In atleast one alternative embodiment, referring again to FIG. 89, the outerlayer 1211 can be sufficiently rigid such that it extends around thebases 1222 without conforming to each base 1222. In any event, invarious embodiments, the outer layer 1311 can be positioned intermediatethe bases 1322 of staples 1320 and a staple cartridge support surface,such as support surfaces 1031 or 1131, for example, supporting thestaple cartridge 1300. In at least one such embodiment, the outer layer1311 can be positioned intermediate the bases 1322 and support slots,such as slots 1032 or 1132, for example, defined in the staple cartridgesupport surface. In at least one such embodiment, further to the above,the outer layer 1311 can be configured to limit the movement of thebases 1322 and/or increase the coefficient of friction between the bases1322 and the staple cartridge support surface and/or support slots inorder to reduce relative movement therebetween. In various alternativeembodiments, referring now to FIGS. 92 and 93, the outer layer of astaple cartridge, such as staple cartridge 1400, for example, may notentirely surround the staples positioned therein. In at least one suchembodiment, an outer layer 1411 of a compressible, implantable cartridgebody 1410 may be assembled to the inner layer 1412 before the staplelegs 1421 of staples 1420 are inserted into the cartridge body 1410. Asa result of the above, the bases 1422 of staples 1420 may extend outsideof the outer layer 1411 and, in at least one such embodiment, the bases1422 may be positioned directly into the support slots 1032 or 1132within the staple cartridge support surfaces 1031 or 1131, for example.In various embodiments, the staple legs 1421 may incise the outer layer1411 when they are inserted therethrough. In various circumstances, theholes created by the staple legs 1421 may closely surround the staplelegs 1421 such that very little, if any, fluid can leak between thestaple legs 1421 and the outer layer 1411 which can reduce thepossibility of, or prevent, the medicament contained within the staplecartridge body 1410 from being activated and/or leaking out of thecartridge body 1410 prematurely.

As discussed above, referring again to FIGS. 88 and 89, the legs 1221 ofthe staples 1220 can be embedded within the cartridge body 1210 and thebases 1222 of staples 1220 may extend outwardly from the bottom surface1218 of the inner layer 1212. In various embodiments, further to theabove, the inner layer 1212 may not comprise staple cavities configuredto receive the staples 1220. In various other embodiments, referring nowto FIGS. 94 and 95, a staple cartridge, such as staple cartridge 1500,for example, may comprise a compressible, implantable cartridge body1510 comprising staple cavities 1515 which can be configured to receiveat least a portion of the staples 1520 therein. In at least one suchembodiment, a top portion of the staple legs 1521 of the staples 1520may be embedded in the inner layer 1512 while a bottom portion of thestaple legs 1521, and the bases 1522, may be positioned within thestaple cavities 1515. In certain embodiments, the bases 1522 may beentirely positioned in the staple cavities 1515 while, in someembodiments, the bases 1522 may at least partially extend below thebottom surface 1518 of the inner layer 1512. Similar to the above, theouter layer 1511 may enclose the inner layer 1512 and the staples 1520positioned therein. In certain other embodiments, referring now to FIG.96, a staple cartridge 1600 may comprise staples 1620 positioned withinstaple cavities 1615 in a compressible, implantable cartridge body 1610wherein at least a portion of the staples 1620 are not enclosed by theouter layer 1611. In at least one such embodiment, each staple 1620 cancomprise staple legs 1621 which are at least partially embedded in theinner layer 1612 and, in addition, bases 1622 which extend outwardlyaround the outer layer 1611.

In various embodiments, referring now to FIGS. 97 and 98, a staplecartridge, such as staple cartridge 1700, for example, can comprise acompressible, implantable cartridge body 1710 and a plurality of staples1720 at least partially positioned within the cartridge body 1710. Thecartridge body 1710 can comprise an outer layer 1711, an inner layer1712, and, in addition, an alignment matrix 1740 which can be configuredto align and/or retain the staples 1720 in position within the cartridgebody 1710. In at least one embodiment, the inner layer 1712 can comprisea recess 1741 which can be configured to receive the alignment matrix1740 therein. In various embodiments, the alignment matrix 1140 can bepress-fit within the recess 1741 and/or otherwise suitably secured tothe inner layer 1712 utilizing at least one adhesive, such as fibrinand/or protein hydrogel, for example. In at least one embodiment, therecess 1741 can be configured such that the bottom surface 1742 ofalignment matrix 1740 is aligned, or at least substantially aligned,with the bottom surface 1718 of the inner layer 1712. In certainembodiments, the bottom surface 1742 of the alignment matrix can berecessed with respect to and/or extend from the bottom surface 1718 ofthe second layer 1712. In various embodiments, each staple 1720 cancomprise a base 1722 and one or more legs 1721 extending from the base1722, wherein at least a portion of the staple legs 1721 can extendthrough the alignment matrix 1740. The alignment matrix 1740 can furthercomprise a plurality of apertures and/or slots, for example, extendingtherethrough which can be configured to receive the staple legs 1721therein. In at least one such embodiment, each aperture can beconfigured to closely receive a staple leg 1721 such that there islittle, if any, relative movement between the staple leg 1721 and thesidewalls of the aperture. In certain embodiments, the alignment matrixapertures may not extend entirely through the alignment matrix 1740 andthe staple legs 1721 may be required to incise the alignment matrix 1740as the staple legs 1721 are pushed therethrough.

In various embodiments, the alignment matrix 1740 can be comprised of amolded plastic body which, in at least one embodiment, can be stiffer orless compressible than the inner layer 1712 and/or the outer layer 1711.In at least one such embodiment, the alignment matrix 1740 can becomprised of a plastic material and/or any other suitable material, suchas polydioxanone (PDS) and/or polyglycolic acid (PGA), for example. Incertain embodiments, the alignment matrix 1740 can be assembled to theinner layer 1712 and the staple legs 1721 can thereafter be insertedthrough the alignment matrix 1740 and embedded into the inner layer1712. In various embodiments, the bottom surface 1742 of the alignmentmatrix 1740 can comprise one or more grooves, slots, or troughs, forexample, which can be configured to at least partially receive the bases1722 of the staples 1720. Similar to the above, the outer layer 1711 canthen be placed around the subassembly comprising the inner layer 1712,the alignment matrix 1740, and the staples 1720. Alternatively, theouter layer 1711 can be placed around a subassembly comprising the innerlayer 1712 and the alignment matrix 1740 wherein the staples 1720 can bethereafter inserted through the outer layer 1711, the alignment matrix1740, and the inner layer 1712. In any event, as a result of the above,the inner layer 1712, the alignment matrix 1740, and/or the outer layer1711 can be configured to retain the staples 1720 in position untiland/or after they are deformed by an anvil as described above. In atleast one such embodiment, the alignment matrix 1740 can serve to holdthe staples 1720 in place before the staple cartridge 1700 is implantedwithin a patient and, in addition, secure the tissue along the stapleline after the staple cartridge 1700 has been implanted. In at least oneembodiment, the staples 1720 may be secured within the alignment matrix1740 without being embedded in the inner layer 1712 and/or the outerlayer 1711, for example.

In various embodiments, referring now to FIGS. 99-105, a staplecartridge, such as staple cartridge 1800, for example, can be assembledby compressing an inner layer 1812, inserting staples, such as staples1820, for example, into the inner layer 1812, and wrapping the innerlayer 1812 with an outer layer 1811. Referring primarily to FIG. 99, acompressible inner layer 1812 is illustrated as comprising a pluralityof staple cavities 1815 defined therein, although other embodiments areenvisioned in which the inner layer 1812 does not comprise staplecavities, as described above. Referring now to FIG. 100, thecompressible inner layer 1812 can be positioned intermediate a transferplate 1850 and a support plate 1860 and compressed between thecompression surfaces 1852 and 1862 thereof, respectively. As illustratedin FIG. 100, the top and bottom surfaces of the inner layer 1812 can becompressed toward one another and, in response thereto, the inner layer1812 can bulge outwardly in the lateral directions. In certainembodiments, the inner layer 1812 can be compressed to a height which isapproximately one-third of its original height, for example, and canhave a height or thickness between approximately 0.06″ and approximately0.08″ in its compressed state, for example. As also illustrated in FIG.100, the transfer plate 1850 can further comprise a plurality ofstaples, such as staples 1820, for example, positioned within aplurality of staple wells 1853. In addition, the transfer plate 1850 canfurther comprise a plurality of drivers 1851 which can be configured topush the staples 1820 upwardly and out of the staple wells 1853.Referring now to FIG. 101, the drivers 1851 can be utilized to push thestaple legs 1821 of the staples 1820 into and through the compressedinner layer 1812. In various embodiments, the drivers 1851 can beconfigured such that the top surfaces thereof are positioned flush, orat least nearly flush, with the compression surface 1852 of the transferplate 1850 when the staples 1820 have been fully deployed from thestaple wells 1853 of transfer plate 1850. In certain embodiments, asalso illustrated in FIG. 101, the support plate 1860 can comprise aplurality of receiving apertures 1861 which can be configured to receivethe staple legs 1821, or at least the tips of the staple legs 1821,after they are pushed through the inner layer 1812. The receivingapertures 1861, or the like, may be necessitated in embodiments wherethe inner layer 1812 has been compressed to a height which is shorterthan the height of the staples 1820 and, thus, when the staples 1820have been fully ejected from the staple wells 1853, the staple legs 1821may protrude from the top surface of the compressed inner layer 1812. Incertain other embodiments, the inner layer 1812 may be compressed to aheight which is taller than the height of the staples 1820 and, as aresult, the receiving apertures 1861 in support plate 1860 may beunnecessary.

After the staples 1820 have been inserted into the inner layer 1812,referring now to FIG. 102, the support plate 1860 can be moved away fromthe transfer plate 1850 in order to allow the inner layer 1812 todecompress. In such circumstances, the inner layer 1812 can resilientlyre-expand to its original, or at least near-original, uncompressedheight. As the inner layer 1812 re-expands, the height of the innerlayer 1812 can increase such that it exceeds the height of the staples1820 and such that the staple legs 1821 of the staples 1820 no longerprotrude from the top surface of the inner layer 1812. In variouscircumstances, the receiving apertures 1861 can be configured to holdthe staple legs 1821 in position at least until the support plate 1860has been sufficiently moved away such that the legs 1821 are no longerpositioned within the receiving apertures 1861. In such circumstances,the receiving apertures 1861 can assist in maintaining the relativealignment of the staples 1820 within the inner layer 1812 as itre-expands. In various circumstances, the inner layer 1812 and thestaples 1820 positioned therein can comprise a subassembly 1801 which,referring now to FIG. 103, can be inserted into an outer layer 1811, forexample. In at least one such embodiment, the outer layer 1811 cancomprise a cavity 1802 defined therein which can be configured toreceive the subassembly 1801 therein. In various circumstances, a tool,such as pliers 1855, for example, can be utilized to pull the outerlayer 1811 onto the subassembly 1801. Once the subassembly 1801 has beensufficiently positioned within the outer layer 1811, referring now toFIG. 104, the outer layer 1811 can be sealed. In various embodiments,the outer layer 1811 can be sealed utilizing the application of heatenergy to a portion thereof. More particularly, in at least oneembodiment, the outer layer 1811 can be comprised of a plastic materialwherein the open end of the outer layer 1811 can be heat-staked by oneor more heated elements, or irons, 1856 in order to bond and/or seal theperimeter of the open end of the outer layer 1811 together. In at leastone such embodiment, referring now to FIG. 105, an excess portion 1857of the outer layer 1811 can be removed and the staple cartridge 1800 canthen be used as described herein.

As described above, a staple cartridge can be positioned within and/orsecured to a staple cartridge attachment portion. In variousembodiments, referring now to FIGS. 106 and 107, a staple cartridgeattachment portion can comprise a staple cartridge channel, such asstaple cartridge channel 1930, for example, which can be configured toreceive at least a portion of a staple cartridge, such as staplecartridge 1900, for example, therein. In at least one embodiment, thestaple cartridge channel 1930 can comprise a bottom support surface1931, a first lateral support wall 1940, and a second lateral supportwall 1941. In use, the staple cartridge 1900 can be positioned withinthe staple cartridge channel 1930 such that the staple cartridge 1900 ispositioned against and/or adjacent to the bottom support surface 1931and positioned intermediate the first lateral support wall 1940 and thesecond lateral support wall 1941. In certain embodiments, the firstlateral support wall 1940 and the second lateral support wall 1941 candefine a lateral gap therebetween. In at least one such embodiment, thestaple cartridge 1900 can comprise a lateral width 1903 which is thesame as and/or wider than the lateral gap defined between the supportwalls 1940 and 1941 such that a compressible, implantable cartridge body1910 of the staple cartridge 1900 can fit securely between the walls1940 and 1941. In certain other embodiments, the lateral width 1903 ofthe staple cartridge 1900 can be shorter than the gap defined betweenthe first and second side walls 1940 and 1941. In various embodiments,at least a portion of the walls 1940 and 1941 and the bottom supportsurface 1931 can be defined by a stamped metal channel while, in atleast one embodiment, at least a portion of the lateral support wall1940 and/or lateral support wall 1941 can be comprised of a flexiblematerial, such as an elastomeric material, for example. Referringprimarily to FIG. 106, the first side wall 1940 and the second side wall1941 of the staple cartridge channel 1930 can each be comprised of arigid portion 1933 extending upwardly from the bottom support surface1931 and a flexible portion 1934 extending upwardly from the rigidportions 1933.

In various embodiments, further to the above, the cartridge body 1910 ofstaple cartridge 1900 can be comprised of one or more compressiblelayers, such as first layer 1911 and second layer 1912, for example.When the cartridge body 1910 is compressed against the bottom supportsurface 1931 by an anvil, as described above, the side portions of thecartridge body 1910 can expand laterally. In embodiments where thestaple cartridge 1930 is comprised of rigid side walls, the lateralexpansion of the cartridge body 1910 can be prevented, or at leastlimited, by the rigid side walls and, as a result, a significant amountof internal pressure, or stress, can be developed within the cartridgebody 1910. In embodiments where at least a portion of the staplecartridge 1930 is comprised of flexible side walls, the flexible sidewalls can be configured to flex laterally and permit the side portionsof the cartridge body 1910 to expand laterally, thereby reducing theinternal pressure, or stress, generated within the cartridge body 1910.In embodiments where the cartridge channel does not comprise lateralside walls, or comprises lateral sidewalls which are relatively shorterthan the staple cartridge, the side portions of the staple cartridge mayexpand laterally uninhibited, or at least substantially uninhibited. Inany event, referring now to FIG. 107, a staple cartridge channel 2030can comprise lateral sidewalls 2040 and 2041 which can be entirelycomprised of a flexible material, such as an elastomeric material, forexample. The staple cartridge channel 2030 can further comprise lateralslots 2033 extending along the sides of the bottom support surface 2031of the staple cartridge channel 2030 which can be configured to receiveand secure at least a portion of the lateral sidewalls 2040 and 2041therein. In certain embodiments, the lateral side walls 2040 and 2041can be secured in the slots 2033 via a snap-fit and/or press-fitarrangement while, in at least some embodiments, the lateral side walls2040 and 2041 can be secured in the slots 2033 by one or more adhesives.In at least one embodiment, the sidewalls 2040 and 2041 may bedetachable from the bottom support surface 2031 during use. In anyevent, a compressible, implantable cartridge body 2010 can be detachedand/or disengaged from the lateral side walls 2040 and 2041 when thecartridge body 2010 is implanted with the staples 2020.

In various embodiments, referring now to FIG. 108, a surgical instrumentcan comprise a shaft 2150 and an end effector extending from the distalend of the shaft 2150. The end effector can comprise, similar to theabove, a staple cartridge channel 2130, an anvil 2140 movable between anopen position and a closed position, and a staple cartridge 2100positioned intermediate the staple cartridge channel 2130 and the anvil2140. Also similar to the above, the staple cartridge 2100 can comprisea compressible, implantable cartridge body 2110 and a plurality ofstaples 2120 positioned in the cartridge body 2110. In variousembodiments, the staple cartridge channel 2130 can comprise, one, abottom support surface 2131 against which the staple cartridge 2100 canbe positioned, two, a distal end 2135 and, three, a proximal end 2136.In at least one embodiment, as illustrated in FIG. 108, the staplecartridge 2100 can comprise a first end 2105 which can be positionablein the distal end 2135 of the staple cartridge channel 2130 and a secondend 2106 which can be positionable in the proximal end 2136 of thestaple cartridge channel 2130. In various embodiments, the distal end2135 of the staple cartridge channel 2130 can comprise at least onedistal retention feature, such as a retention wall 2137, for example,and, similarly, the proximal end 2136 can comprise at least one proximalretention feature, such as a retention wall 2138, for example. In atleast one such embodiment, the distal retention wall 2137 and theproximal retention wall 2138 can define a gap therebetween which can beequal to or less than the length of the staple cartridge 2100 such thatthe staple cartridge 2100 can fit securely within the staple cartridgechannel 2130 when the staple cartridge 2100 is inserted therein.

In various embodiments, referring again to FIGS. 88 and 89, a staplecartridge, such as staple cartridge 1200, for example, can comprise aflat, or at least substantially flat, tissue-contacting surface 1219. Inat least one such embodiment, the staple cartridge body 1210 of staplecartridge 1200 can comprise a first end 1205 which can be defined by afirst height, or thickness, 1207 and a second end 1206 which can bedefined by a second height, or thickness, 1208, wherein the first height1207 can be equal to, or at least substantially equal to, the secondheight 1208. In certain embodiments, the cartridge body 1210 cancomprise a constant, or at least substantially constant, height, orthickness, between the first end 1205 and the second end 1206. In atleast one such embodiment, the tissue-contacting surface 1219 can beparallel, or at least substantially parallel, to the bottom surface 1218of the cartridge body 1210. In various embodiments, referring once againto FIG. 108, the first end 2105 of the cartridge body 2110 of staplecartridge 2100 can be defined by a first height 2107 which is differentthan a second height 2108 of the second end 2106. In the illustratedembodiment, the first height 2107 is larger than the second height 2108,although the second height 2108 could be larger than the first height2107 in alternative embodiments. In various embodiments, the height ofthe cartridge body 2110 can decrease linearly and/or geometricallybetween the first end 2105 and the second end 2106. In at least one suchembodiment, the tissue-contacting surface 2119, which extends betweenthe first end 2105 and the second end 2106, can be oriented along anangle defined therebetween. In at least one such embodiment, thetissue-contacting surface 2119 may not be parallel to the bottom surface2118 of the cartridge body 2110 and/or parallel to the support surface2131 of the staple cartridge channel 2130.

In various embodiments, referring again to FIGS. 108 and 109, the anvil2140 can comprise a tissue-contacting surface 2141 which can beparallel, or at least substantially parallel, to the support surface2131 of the staple cartridge channel 2130 when the anvil 2140 is in aclosed position, as illustrated in FIG. 109. When the anvil 2140 is in aclosed position, the anvil 2140 can be configured to compress the firstend 2105 of the staple cartridge 2100 more than the second end 2106owing to the taller height of the first end 2105 and the shorter heightof the second end 2106. In some circumstances, including circumstanceswhere the tissue T positioned intermediate the tissue contactingsurfaces 2119 and 2141 has a constant, or at least substantiallyconstant, thickness, the pressure generated within the tissue T and thecartridge 2100 can be greater at the distal end of the end effector thanthe proximal end of the end effector. More particularly, when the tissueT between the anvil 2140 and the staple cartridge 2100 has asubstantially constant thickness, the tissue T positioned intermediatethe distal end 2145 of the anvil 2140 and the first end 2105 of thestaple cartridge 2100 can be more compressed than the tissue Tpositioned intermediate the proximal end 2146 of the anvil 2140 and thesecond end 2106 of the staple cartridge 2100. In various embodiments, apressure gradient can be generated within the tissue T between theproximal end and the distal end of the end effector. More particularly,in at least one embodiment, when the tissue T between the anvil 2140 andthe staple cartridge 2100 has a substantially constant thickness and theheight of the staple cartridge 2100 decreases linearly from the distalend to the proximal end of the end effector, the pressure within thetissue T can decrease linearly from the distal end of the end effectorto the proximal end of the end effector. Similarly, in at least oneembodiment, when the tissue T between the anvil 2140 and the staplecartridge 2100 has a substantially constant thickness and the height ofthe staple cartridge 2100 decreases geometrically from the distal end tothe proximal end of the end effector, the pressure within the tissue Tcan decrease geometrically from the distal end of the end effector tothe proximal end of the end effector.

In various embodiments, referring again to FIG. 108, the tissue Tpositioned intermediate the staple cartridge 2100 and the anvil 2140 maynot have a constant thickness throughout. In at least one suchcircumstance, the tissue T positioned between the proximal end 2146 ofthe anvil 2140 and the second end 2106 of the staple cartridge 2100 maybe thicker than the tissue T positioned between the distal end 2145 ofthe anvil 2140 and the first end 2105 of the staple cartridge 2100. Insuch circumstances, as a result, the thicker tissue T may be generallypositioned above the shorter proximal end 2106 of the staple cartridge2100 and the thinner tissue T may be generally positioned above thetaller distal end 2105. In use, the firing collar 2152 of the shaft 2150can be advanced distally along the shaft spine 2151 such that the firingcollar 2152 engages the cam portion 2143 of the anvil 2140 and rotatesthe anvil 2140 toward the staple cartridge 2100 as illustrated in FIG.109. Once the anvil 2140 has been rotated into a fully-closed position,the tissue T may be compressed between the tissue-contacting surfaces2119 and 2141 and, even though the height of the staple cartridge 2100may not be constant between the proximal and distal ends of the endeffector, the pressure or compressive forces applied to the tissue T maybe constant, or at least substantially constant, thereacross. Moreparticularly, as the thinner tissue T may be associated with the tallerheight of the staple cartridge 2100 and the thicker tissue T may beassociated with the shorter height of the staple cartridge 2100, thecumulative, or summed, height of the tissue T and the staple cartridge2100 may be constant, or at least substantially constant, between theproximal and distal ends of the end effector and, as a result, thecompression of this cumulative height by the anvil 2140 may be constant,or at least substantially constant, thereacross.

In various embodiments, referring again to FIGS. 108 and 109, the staplecartridge 2100 can comprise an asymmetrical configuration. In at leastone such embodiment, for example, the height of the staple cartridge2100 at the first end 2105 thereof may be higher than the height of thestaple cartridge 2100 at the second end 2106 thereof. In certainembodiments, the staple cartridge 2100 and/or the staple cartridgechannel 2130 can comprise one or more alignment and/or retentionfeatures which can be configured to assure that the staple cartridge2100 can only be positioned within the staple cartridge channel 2130 inone orientation, i.e., an orientation in which the first end 2105 ispositioned in the distal end 2135 of the staple cartridge channel 2130and the second end 2106 is positioned in the proximal end 2136. Invarious alternative embodiments, the staple cartridge 2100 and/or thestaple cartridge channel 2130 can comprise one or more alignment and/orretention features which can be configured to permit the staplecartridge 2100 to be positioned within the staple cartridge channel 2130in more than one orientation. Referring now to FIG. 110, for example,the staple cartridge 2100 can be positioned within the staple cartridgechannel 2130 such that the first end 2105 of the staple cartridge 2100can be positioned in the proximal end 2136 of the staple cartridgechannel 2130 and the second end 2106 can be positioned in the distal end2135. In various embodiments, as a result, the shorter height of thestaple cartridge 2100 can be positioned proximate the distal retentionwall 2137 and the taller height of the staple cartridge 2100 can bepositioned proximate to the proximal retention wall 2138. In at leastone such embodiment, the staple cartridge 2100 can be suitably arrangedto apply a constant, or at least substantially constant, clampingpressure to tissue T having a thicker portion within the distal end ofthe end effector and a thinner portion within the proximal end of theend effector. In various embodiments, the staple cartridge 2100, forexample, can be selectively oriented within the staple cartridge channel2130. In at least one such embodiment, the alignment and/or retentionfeatures of the staple cartridge 2100 can be symmetrical and a surgeoncan selectively orient the staple cartridge 2100 within the staplecartridge channel 2130 in the orientations depicted in FIG. 108 and FIG.110, for example.

Further to the above, the implantable cartridge body 2110 can comprise alongitudinal axis 2109 which, when the staple cartridge 2100 ispositioned in the staple cartridge channel 2130, can extend between theproximal and distal ends of the end effector. In various embodiments,the thickness of the cartridge body 2110 can generally decrease and/orgenerally increase between the first end 2105 and the second end 2106along the longitudinal axis 2109. In at least one such embodiment, thedistance, or height, between the bottom surface 2118 and thetissue-contacting surface 2119 can generally decrease and/or generallyincrease between the first end 2105 and the second end 2106. In certainembodiments, the thickness of the cartridge body 2110 can both increaseand decrease along the longitudinal axis 2109. In at least one suchembodiment, the thickness of the cartridge body 2110 can comprise one ormore portions which increase in thickness and one or more portions whichcan decrease in thickness. In various embodiments, referring again toFIG. Z, the staple cartridge 2100 can comprise a plurality of staples2120 positioned therein. In use, as described above, the staples 2120can be deformed when the anvil 2140 is moved into a closed position. Incertain embodiments, each staple 2120 can have the same, or at leastsubstantially the same, height. In at least one such embodiment, theheight of a staple can be measured from the bottom of the base of thestaple to the top, or tip, of the tallest leg of the staple, forexample.

In various embodiments, the staples within a staple cartridge can havedifferent staple heights. In at least one such embodiment, a staplecartridge can comprise a first group of staples having a first stapleheight which are positioned in a first portion of a compressiblecartridge body and a second group of staples having a second stapleheight which are positioned in a second portion of the compressiblecartridge body. In at least one embodiment, the first staple height canbe taller than the second staple height and the first group of staplescan be positioned in the first end 2105 of the staple cartridge 2100while the second group of staples can be positioned in the second end2106. Alternatively, the taller first group of staples can be positionedin the second end 2106 of the staple cartridge 2100 while the shortersecond group of staples can be positioned in the first end 2105. Incertain embodiments, a plurality of staple groups, each group having adifferent staple height, can be utilized. In at least one suchembodiment, a third group having an intermediate staple height can bepositioned in the cartridge body 2110 intermediate the first group ofstaples and the second group of staples. In various embodiments, eachstaple within a staple row in the staple cartridge can comprise adifferent staple height. In at least one embodiment, the tallest staplewithin a staple row can be positioned on a first end of a staple row andthe shortest staple can be positioned on an opposite end of the staplerow. In at least one such embodiment, the staples positionedintermediate the tallest staple and the shortest staple can be arrangedsuch that the staple heights descend between the tallest staple and theshortest staple, for example.

In various embodiments, referring now to FIG. 111, an end effector of asurgical stapler can comprise an anvil 2240, a staple cartridge channel2230, and a staple cartridge 2200 supported by the staple cartridgechannel 2230. The staple cartridge 2200 can comprise a compressible,implantable cartridge body 2210 and a plurality of staples, such asstaples 2220 a and staples 2220 b, for example, positioned therein. Invarious embodiments, the staple cartridge channel 2230 can comprise acartridge support surface 2231 and a plurality of staple support slots,such as support slots 2232 a and 2232 b, for example, defined therein.In at least one such embodiment, the staple cartridge 2200 can comprisetwo outer rows of staples 2220 a and two inner rows of staples 2220 b,wherein the support slots 2232 a can be configured to support thestaples 2220 a and the support slots 2232 b can be configured to supportthe staples 2220 b. Referring to FIGS. 111 and 112, the anvil 2240 cancomprise a plurality of staple forming pockets 2242 defined thereinwhich can be configured to receive and deform the staples 2220 a and2220 b when the anvil 2240 is moved toward the staple cartridge 2200. Inat least one such embodiment, the bottom surfaces of the support slots2232 a can be a first distance 2201 a away from the top surfaces of thestaple forming pockets 2242 while the bottom surfaces of the supportslots 2232 b can be a second distance 2201 b away from the top surfacesof the staple forming pockets 2242. In at least one such embodiment, thesupport slots 2232 b are positioned closer to the anvil 2240 owing tothe raised step in the support surface 2231 in which they are defined.Owing to the different distances 2201 a and 2201 b, in variousembodiments, the outer rows of staples 2220 a and the inner rows ofstaples 2220 b can be deformed to different formed heights. In variouscircumstances, staples deformed to different formed heights can applydifferent clamping pressures or forces to the tissue T being stapled. Inaddition to the above, the staples can begin with different unformedstaple heights. In at least one such embodiment, referring again to FIG.111, the outer staples 2220 a can have an initial, unformed height whichis greater than the initial, unformed height of the inner staples 2220b. As illustrated in FIGS. 111 and 112, the inner staples 2220 b, whichhave a shorter unformed height than the outer staples 2220 a, can alsohave a shorter formed height than the outer staples 2220 b. In variousalternative embodiments, the inner staples 2220 b may have a tallerunformed height than the outer staples 2220 a yet have a shorterdeformed staple height than the outer staples 2220 a.

In various embodiments, further to the above, the anvil 2240 can bemoved into a closed position, as illustrated in FIG. 112, in order tocompress the cartridge body 2210 and deform the staples 2220 a and 2220b. In certain embodiments, a surgical stapler comprising the endeffector depicted in FIGS. 111 and 112, for example, can furthercomprise a cutting member which can be configured to transect the tissueT positioned intermediate the anvil 2240 and the staple cartridge 2200.In at least one such embodiment, the anvil 2240, the staple cartridgechannel 2230 and/or the staple cartridge 2200 can define a slotconfigured to slidably receive a cutting member therein. Moreparticularly, the anvil 2240 can comprise a slot portion 2249, thestaple cartridge channel 2230 can comprise a slot portion 2239, and thestaple cartridge 2200 can comprise a slot portion 2203 which can bealigned, or at least substantially aligned, with one another when theanvil 2240 is in a closed, or at least substantially closed, position.In various embodiments, the cutting member can be moved from theproximal end of the end effector toward the distal end of the endeffector after the anvil 2240 has been closed and the staples 2220 a,2220 b have been deformed. In at least one embodiment, the cuttingmember can be moved independently of the staple deformation process. Incertain embodiments, the cutting member can be advanced at the same timethat the staples are being deformed. In any event, in at least oneembodiment, the cutting member can be configured to incise the tissuealong a path positioned intermediate the inner rows of staples 2220 b.

In various embodiments, as illustrated in FIG. 112, the inner staples2220 b can be formed to a shorter height than the outer staples 2220 awherein the inner staples 2220 b can apply a larger clamping pressure orforce to the tissue adjacent to the cut line created by the cuttingmember. In at least one such embodiment, the larger clamping pressure orforce created by the inner staples 2220 b can provide varioustherapeutic benefits such as reducing bleeding from the incised tissue Twhile the smaller clamping pressure created by the outer staples 2220 acan provide flexibility within the stapled tissue. In variousembodiments, referring again to FIGS. 111 and 112, the anvil 2240 canfurther comprise at least one piece of buttress material, such asbuttress material 2260, for example, attached thereto. In at least onesuch embodiment, the legs of the staples 2220 a, 2220 b can beconfigured to incise the buttress material 2260 and/or pass throughapertures in the buttress material 2260 when the staple cartridge 2200is compressed by the anvil 2240 and thereafter contact the stapleforming pockets 2242 in the anvil 2240. As the legs of the staples 2220a, 2220 b are being deformed, the legs can contact and/or incise thebuttress material 2260 once again. In various embodiments, the buttressmaterial 2260 can improve the hemostasis of and/or provide strength tothe tissue being stapled.

In various embodiments, referring again to FIGS. 111 and 112, the bottomsurface of the cartridge body 2210 can comprise a stepped contour whichmatches, or at least substantially matches, the stepped contour of thecartridge support surface 2231. In certain embodiments, the bottomsurface of the cartridge body 2210 can deform to match, or at leastsubstantially match, the contour of the cartridge support surface 2231.In various embodiments, referring now to FIG. 113, an end effector,similar to the end effector depicted in FIG. 111, for example, cancomprise a staple cartridge 2300 positioned therein. The staplecartridge 2300 can comprise a compressible, implantable body 2310comprising an inner layer 2312 and an outer layer 2311 wherein, furtherto the above, the outer layer 2311 can be comprised of a waterimpermeable material in at least one embodiment. In various embodiments,the outer layer 2311 can extend around the staples 2220 a, 2220 b andcan be positioned intermediate the staples 2220 a, 2220 b and thesupport slots 2232 a, 2232 b, respectively. In various embodiments,referring now to FIG. 114, an end effector, similar to the end effectordepicted in FIG. 111, for example, can comprise a staple cartridge 2400positioned therein. Similar to the staple cartridge 2300, thecompressible, implantable cartridge body 2410 of staple cartridge 2400can comprise an inner layer 2412 and an outer layer 2411; however; in atleast one embodiment, the cartridge body 2410 may not comprise a cuttingmember slot therein. In at least one such embodiment, the cutting membermay be required to incise the inner layer 2412 and/or the outer layer2411, for example, as it is advanced through the staple cartridge.

In various embodiments, referring now to FIG. 115, an end effector of asurgical stapler can comprise an anvil 2540, a staple cartridge channel2530, and a staple cartridge 2500 positioned in the staple cartridgechannel 2530. Similar to the above, the staple cartridge 2500 cancomprise a compressible, implantable cartridge body 2510, outer rows ofstaples 2220 a, and inner rows of staples 2220 b. The staple cartridgechannel 2530 can comprise a flat, or an at least substantially flat,cartridge support surface 2531 and staple support slots 2532 definedtherein. The anvil 2540 can comprise a stepped surface 2541 and aplurality of staple forming pockets, such as forming pockets 2542 a and2542 b, for example, defined therein. Similar to the above, the formingpockets 2542 a and the support slots 2532 can define a distancetherebetween which is greater than the distance between the formingpockets 2452 b and the support slots 2532. In various embodiments, theanvil 2540 can further comprise a piece of buttress material 2560attached to the stepped surface 2541 of the anvil 2540. In at least onesuch embodiment, the buttress material 2560 can conform, or at leastsubstantially conform, to the stepped surface 2541. In variousembodiments, the buttress material 2560 can be removably attached to thesurface 2541 by at least one adhesive, such as fibrin and/or proteinhydrogel, for example. In certain embodiments, the cartridge body 2510can also comprise a stepped profile which, in at least one embodiment,parallels, or at least substantially parallels, the stepped surface 2541of the anvil 2540. More particularly, in at least one embodiment, theanvil 2540 can comprise steps 2548 extending toward the staple cartridge2500 wherein the steps 2548 can comprise a step height which equals, orat least substantially equals, the step height of the steps 2508extending from the cartridge body 2510. In at least one such embodiment,as a result of the above, the amount of the compressible cartridge body2510 that can be captured in the first staples 2220 a can be differentthan the amount of the compressible cartridge body 2510 that can becaptured in the second staples 2220 b, for example.

In various embodiments, referring now to FIG. 116, an end effector cancomprise an anvil 2640, a staple cartridge channel 2530, and a staplecartridge 2600 positioned therebetween. The staple cartridge 2600 cancomprise a compressible, implantable cartridge body 2610 including aninner layer 2612, an outer layer 2611, and a plurality of staples, suchas staples 2220 a and 2200 b, for example, positioned therein. Invarious embodiments, the anvil 2640 can comprise a plurality of stapleforming pockets 2642 in surface 2641 and the staple cartridge channel2530 can comprise a plurality of staple forming slots 2532 defined inthe support surface 2531. As illustrated in FIG. 116, the anvil surface2641 can be parallel, or at least substantially parallel, to thecartridge support surface 2531 wherein each forming pocket 2642 can bepositioned an equal, or at least substantially equal, distance away froman opposing and corresponding staple support slot 2532. In variousembodiments, the staple cartridge 2600 can comprise staples having thesame, or at least substantially the same, initial, unformed stapleheight and, in addition, the same, or at least substantially the same,formed staple height. In certain other embodiments, the outer rows ofstaples can comprise staples 2220 a and the inner rows of staples cancomprise staples 2220 b wherein, as discussed above, the staples 2220 aand 2220 b can have different unformed staple heights. When the anvil2640 is moved toward the staple cartridge 2600 into a closed position,the staples 2220 a and 2220 b can be formed such that they have thesame, or at least substantially the same, formed staple height. In atleast one such embodiment, as a result of the above, the formed outerstaples 2220 a and the inner staples 2220 b may have the same, or atleast substantially the same, amount of compressible cartridge body 2610contained therein; however, as the outer staples 2220 a have a tallerunformed staple height than the inner staples 2220 b and may have thesame formed staple height nonetheless, a greater clamping pressure canbe generated in the outer staples 2220 a than the inner staples 2220 b,for example.

In various embodiments, referring now to FIG. 117, an end effector of asurgical stapler can comprise an anvil 2740, a staple cartridge channel2530, and a staple cartridge 2700 positioned within the staple cartridgechannel 2530. Similar to the above, the staple cartridge 2700 cancomprise a compressible, implantable cartridge body 2710 comprising aninner layer 2712, an outer layer 2711, and a plurality of staples, suchas staples 2220 a and 2220 b, for example, positioned therein. In atleast one embodiment, the thickness of the cartridge body 2710 can varyacross its width. In at least one such embodiment, the cartridge body2710 can comprise a center portion 2708 and side portions 2709, whereinthe center portion 2708 can comprise a thickness which is greater thanthe thickness of the side portions 2709. In various embodiments, thethickest portion of the cartridge body 2710 can be located at the centerportion 2708 while the thinnest portion of the cartridge body 2710 canbe located at the side portions 2709. In at least one such embodiment,the thickness of the cartridge body 2710 can decrease gradually betweenthe center portion 2708 and the side portions 2709. In certainembodiments, the thickness of the cartridge body 2710 can decreaselinearly and/or geometrically between the center portion 2708 and theside portions 2709. In at least one such embodiment, thetissue-contacting surface 2719 of cartridge body 2710 can comprise twoinclined, or angled, surfaces which slope downwardly from the centerportion 2708 toward the side portions 2709. In various embodiments, theanvil 2740 can comprise two inclined, or angled, surfaces whichparallel, or at least substantially parallel, the inclinedtissue-contacting surfaces 2719. In at least one embodiment, the anvil2740 can further comprise at least one piece of buttress material 2760attached to the inclined surfaces of the anvil 2740.

In various embodiments, further to the above, the inner rows of staplesin the staple cartridge 2700 can comprise the taller staples 2220 a andthe outer rows of staples can comprise the shorter staples 2220 b. In atleast one embodiment, the taller staples 2220 a can be positioned withinand/or adjacent to the thicker center portion 2708 while the staples2220 b can be positioned within and/or adjacent to the side portions2709. In at least one such embodiment, as a result of the above, thetaller staples 2220 a can capture more material of the implantablecartridge body 2710 than the shorter staples 2220 b. Such circumstancescould result in the staples 2220 a applying a greater clamping pressureto the tissue T than the staples 2220 b. In certain embodiments, eventhough the taller staples 2220 a may capture more material of thecartridge body 2710 therein than the shorter staples 2220 b, the tallerstaples 2220 a may have a taller formed staple height than the shorterstaples 2220 b owing to the inclined arrangement of the staple formingpockets 2742 a and 2742 b. Such considerations can be utilized toachieve a desired clamping pressure within the tissue captured by thestaples 2220 a and 2220 b wherein, as a result, the clamping pressure inthe staples 2220 a can be greater than, less than, or equal to theclamping pressure applied to the tissue by the staples 2220 b, forexample. In various alternative embodiments to the end effectorillustrated in FIG. 117, the shorter staples 2220 b can be positionedwithin and/or adjacent to the thicker center portion 2708 of thecartridge body 2710 and the taller staples 2220 a can be positionedwithin and/or adjacent to the thinner side portions 2709. Furthermore,although the staple cartridge 2700 is depicted as comprising inner andouter rows of staples, the staple cartridge 2700 may comprise additionalrows of staples, such as staple rows positioned intermediate the innerand outer rows of staples, for example. In at least one such embodiment,the intermediate staple rows can comprise staples having an unformedstaple height which is intermediate the unformed staple heights of thestaples 2220 a and 2220 b and a formed staple height which isintermediate the formed staple heights of the staples 2220 a and 2220 b,for example.

In various embodiments, referring now to FIG. 118, an end effector of asurgical stapler can comprise an anvil 2840, a staple cartridge channel2530, and a staple cartridge 2800 positioned within the staple cartridgechannel 2530. Similar to the above, the staple cartridge 2800 cancomprise a compressible, implantable cartridge body 2810 comprising aninner layer 2812, an outer layer 2811, and a plurality of staples, suchas staples 2220 a and 2220 b, for example, positioned therein. In atleast one embodiment, the thickness of the cartridge body 2810 can varyacross its width. In at least one such embodiment, the cartridge body2810 can comprise a center portion 2808 and side portions 2809, whereinthe center portion 2808 can comprise a thickness which is less than thethickness of the side portions 2809. In various embodiments, thethinnest portion of the cartridge body 2810 can be located at the centerportion 2808 while the thickest portion of the cartridge body 2810 canbe located at the side portions 2809. In at least one such embodiment,the thickness of the cartridge body 2810 can increase gradually betweenthe center portion 2808 and the side portions 2809. In certainembodiments, the thickness of the cartridge body 2810 can increaselinearly and/or geometrically between the center portion 2808 and theside portions 2809. In at least one such embodiment, thetissue-contacting surface 2819 of cartridge body 2810 can comprise twoinclined, or angled, surfaces which slope upwardly from the centerportion 2808 toward the side portions 2809. In various embodiments, theanvil 2840 can comprise two inclined, or angled, surfaces whichparallel, or at least substantially parallel, the inclinedtissue-contacting surfaces 2819. In at least one embodiment, the anvil2840 can further comprise at least one piece of buttress material 2860attached to the inclined surfaces of the anvil 2840. In variousembodiments, further to the above, the outer rows of staples in thestaple cartridge 2800 can comprise the taller staples 2220 a and theinner rows of staples can comprise the shorter staples 2220 b. In atleast one embodiment, the taller staples 2220 a can be positioned withinand/or adjacent to the thicker side portions 2809 while the staples 2220b can be positioned within and/or adjacent to the center portion 2808.In at least one such embodiment, as a result of the above, the tallerstaples 2220 a can capture more material of the implantable cartridgebody 2810 than the shorter staples 2220 b.

As described above with regard to the embodiment of FIG. 111, forexample, the staple cartridge channel 2230 can comprise a steppedsupport surface 2231 which can be configured to support the staples 2220a and 2220 b at different heights with respect the anvil 2240. Invarious embodiments, the staple cartridge channel 2230 can be comprisedof metal and the steps in the support surface 2231 may be formed in thesupport surface 2231 by a grinding operation, for example. In variousembodiments, referring now to FIG. 119, an end effector of a surgicalinstrument can comprise a staple cartridge channel 2930 comprising asupport insert 2935 positioned therein. More particularly, in at leastone embodiment, the staple cartridge channel 2930 can be formed suchthat it has a flat, or at least substantially flat, support surface2931, for example, which can be configured to support the insert 2935which comprises the stepped surfaces for supporting the staples 2220 aand 2220 b of the staple cartridge 2200 at different heights. In atleast one such embodiment, the insert 2935 can comprise a flat, or atleast substantially flat, bottom surface which can be positioned againstthe support surface 2931. The insert 2935 can further comprise supportslots, grooves, or troughs 2932 a and 2932 b which can be configured tosupport the staples 2220 a and 2220 b, respectively, at differentheights. Similar to the above, the insert 2935 can comprise a knife slot2939 defined therein which can be configured to permit a cutting memberto pass therethrough. In various embodiments, the staple cartridgechannel 2930 can be comprised of the same material as or a differentmaterial than the support insert 2935. In at least one embodiment, thestaple cartridge channel 2930 and the support insert 2935 can both becomprised of metal, for example, while, in other embodiments, the staplecartridge channel 2930 can be comprised of metal, for example, and thesupport insert 2935 can be comprised of plastic, for example. In variousembodiments, the support insert 2935 can be fastened and/or welded intothe staple cartridge channel 2930. In certain embodiments, the supportinsert 2935 can be snap-fit and/or press-fit into the staple cartridgechannel 2930. In at least one embodiment the support insert 2935 can besecured in the staple cartridge channel 2930 using an adhesive.

In various embodiments, referring now to FIG. 120, an end effector of asurgical stapler can comprise an anvil 3040, a staple cartridge channel3030, and a compressible, implantable staple cartridge 3000 positionedin the staple cartridge channel 3030. Similar to the above, the anvil3040 can comprise a plurality of staple-forming pockets 3042 definedtherein and a knife slot 3049 which can be configured to slidablyreceive a cutting member therein. Also similar to the above, the staplecartridge channel 3030 can comprise a plurality of staple support slots3032 defined therein and a knife slot 3039 which can also be configuredto slidably receive a cutting member therein. In various embodiments,the staple cartridge 3000 can comprise a first layer 3011, a secondlayer 3012, and a plurality of staples, such as staples 3020 a and 3020b, for example, positioned therein. In at least one embodiment, thestaples 3020 a can comprise an unformed staple height which is tallerthan the unformed staple height of the staples 3020 b. In variousembodiments, the first layer 3011 can be comprised of a firstcompressible material and the second layer 3012 can be comprised of asecond compressible material. In certain embodiments, the firstcompressible material can be compressed at a rate which is higher thanthe second compressible material while, in certain other embodiments,the first compressible material can be compressed at a rate which islower than the second compressible material. In at least one embodiment,the first compressible material can be comprised of a resilient materialwhich can comprise a first spring rate and the second compressiblematerial can be comprised of a resilient material which can comprise asecond spring rate which is different than the first spring rate. Invarious embodiments, the first compressible material can comprise aspring rate which is greater than the spring rate of the secondcompressible material. In certain other embodiments, the firstcompressible material can comprise a spring rate which is less than thespring rate of the second compressible material. In various embodiments,the first compressible layer can comprise a first stiffness and thesecond compressible layer can comprise a second stiffness, wherein thefirst stiffness is different than the second stiffness. In variousembodiments, the first compressible layer can comprise a stiffness whichis greater than the stiffness of the second compressible layer. Incertain other embodiments, the first compressible layer can comprise astiffness which is less than the stiffness of the second compressiblelayer.

In various embodiments, referring again to FIG. 120, the second layer3012 of the staple cartridge 3000 can comprise a constant, or at leastsubstantially constant, thickness across the width thereof. In at leastone embodiment, the first layer 3011 can comprise a thickness whichvaries across the width thereof. In at least one such embodiment, thefirst layer 3011 can comprise one or more steps 3008 which can increasethe thickness of the cartridge body 3010 in certain portions of thecartridge body 3010, such as the center portion, for example. Referringagain to FIG. 120, the shorter staples 3020 b can be positioned in oraligned with the steps 3008, i.e., the thicker portions of the cartridgebody 3010, and the taller staples 3020 a can be positioned in or alignedwith the thinner portions of the cartridge body 3010. In variousembodiments, as a result of the thicker and thinner portions of thecartridge body 3010, the stiffness of the cartridge body 3010 can begreater along the inner rows of staples 3020 b than the outer rows ofstaples 3020 a. In various embodiments, the first layer 3011 can beconnected to the second layer 3012. In at least one such embodiment, thefirst layer 3011 and the second layer 3012 can comprise interlockingfeatures which can retain the layers 3011 and 3012 together. In certainembodiments, the first layer 3011 can comprise a first laminate and thesecond layer 3012 can comprise a second laminate, wherein the firstlaminate can be adhered to the second laminate by one or more adhesives.In various embodiments, the staple cartridge 3000 can comprise a knifeslot 3003 which can be configured to slidably receive a cutting membertherein.

In various embodiments, referring now to FIG. 121, a staple cartridge3100 can comprise a compressible, implantable cartridge body 3110comprising a single layer of compressible material and, in addition, aplurality of staples, such as staples 3020 b, for example, positionedtherein. In at least one embodiment, the thickness of the cartridge body3110 can vary across the width thereof. In at least one such embodiment,the cartridge body 3110 can comprise steps 3108 extending along the sideportions thereof. In various embodiments, referring now to FIG. 122, astaple cartridge 3200 can comprise a compressible, implantable cartridgebody 3210 comprising a single layer of compressible material and, inaddition, a plurality of staples, such as staples 3020 b, for example,positioned therein. In at least one embodiment, the thickness of thecartridge body 3210 can vary across the width thereof. In at least onesuch embodiment, the cartridge body 3210 can comprise steps 3208extending along the center portion thereof. In various embodiments,referring now to FIG. 123, a staple cartridge 3300 can comprise acompressible, implantable cartridge body 3310 wherein, similar to theabove, the thickness of the cartridge body 3310 can vary across thewidth thereof. In at least one embodiment, the thickness of thecartridge body 3310 can increase geometrically between the side portionsand the center portion of the cartridge body 3310. In at least one suchembodiment, the thickness of the cartridge body 3310 can be defined byan arcuate or curved profile and can comprise an arcuate or curvedtissue-contacting surface 3319. In certain embodiments, the thickness ofthe cartridge body 3310, and the contour of the tissue-contactingsurface 3319, can be defined by one radius of curvature or,alternatively, by several radiuses of curvature, for example. In variousembodiments, referring now to FIG. 124, a staple cartridge 3400 cancomprise a compressible, implantable cartridge body 3410 wherein thethickness of the cartridge body 3410 can increase linearly, or at leastsubstantially linearly, between the side portions and the center portionof the cartridge body 3410.

In various embodiments, referring now to FIG. 125, a staple cartridge3500 can comprise a compressible, implantable cartridge body 3510 and aplurality of staples 3520 positioned therein. The implantable cartridgebody 3510 can comprise a first inner layer 3512, a second inner layer3513, and an outer layer 3511. In at least one embodiment, the firstinner layer 3512 can comprise a first thickness and the second innerlayer 3513 can comprise a second thickness wherein the second innerlayer 3513 can be thicker than the first inner layer 3512. In at leastone alternative embodiment, the first inner layer 3512 can be thickerthan the second inner layer 3513. In another alternative embodiment, thefirst inner layer 3512 can have the same, or at least substantially thesame, thickness as the second inner layer 3513. In certain embodiments,each staple 3520 can comprise a base 3522 and one or more deformablelegs 3521 extending from the base 3522. In various embodiments, each leg3521 can comprise a tip 3523 which is embedded in the first inner layer3511 and, in addition, each base 3522 of the staples 3520 can beembedded in the second inner layer 3512. In at least one embodiment, thefirst inner layer 3512 and/or the second inner layer 3513 can compriseat least one medicament stored therein and, in various embodiments, theouter layer 3511 can encapsulate and seal the first inner layer 3512 andthe second inner layer 3513 such that the medicament does not flow outof the staple cartridge body 3510 until after the outer layer 3511 hasbeen punctured by the staples 3520. More particularly, further to theabove, an anvil can be pushed downwardly against tissue positionedagainst the tissue-contacting surface 3519 of staple cartridge 3500 suchthat the cartridge body 3510 is compressed and the surface 3519 is moveddownwardly toward, and at least partially below, the staple tips 3523such that the tips 3523 rupture or puncture the outer layer 3511. Afterthe outer layer 3511 has been breached by the staple legs 3521, the atleast one medicament M can flow out of the cartridge body 3510 aroundthe staple legs 3521. In various circumstances, additional compressionof the cartridge body 3510 can squeeze additional medicament M out ofthe cartridge body 3510 as illustrated in FIG. 126.

In various embodiments, referring again to FIG. 125, the outer layer3511 can comprise a water impermeable, or at least substantiallyimpermeable, wrap which can configured to, one, keep the medicament fromprematurely flowing out of the staple cartridge 3500 and, two, preventfluids within a surgical site, for example, from prematurely enteringinto the staple cartridge 3500. In certain embodiments, the first innerlayer 3512 can comprise a first medicament stored, or absorbed, thereinand the second inner layer 3513 can comprise a second medicament stored,or absorbed, therein, wherein the second medicament can be differentthan the first medicament. In at least one embodiment, an initialcompression of the cartridge body 3510, which causes the rupture of theouter layer 3511, can generally express the first medicament out of thefirst inner layer 3512 and a subsequent compression of the cartridgebody 3510 can generally express the second medicament out of the secondinner layer 3513. In such embodiments, however, portions of the firstmedicament and the second medicament may be expressed simultaneouslyalthough a majority of the medicament that is initially expressed can becomprised of the first medicament and a majority of the medicamentsubsequently expressed thereafter can be comprised of the secondmedicament. In certain embodiments, further to the above, the firstinner layer 3512 can be comprised of a more compressible material thanthe second inner layer 3513 such that the initial compression forces orpressure, which can be lower than the subsequent compression forces orpressure, can cause a larger initial deflection within the first innerlayer 3512 than the second inner layer 3513. This larger initialdeflection within the first inner layer 3512 can cause a larger portionof the first medicament to be expressed from the first inner layer 3512than the second medicament from the second inner layer 3513. In at leastone embodiment, the first inner layer 3512 can be more porous and/ormore flexible than the second inner layer 3513. In at least one suchembodiment, the first inner layer 3512 can comprise a plurality ofpores, or voids, 3508 defined therein and the second inner layer 3513can comprise a plurality of pores, or voids, 3509 defined thereinwherein, in various embodiments, the pores 3508 can be configured tostore the first medicament in the first inner layer 3512 and the pores3509 can be configured to store the second medicament in the secondinner layer 3513. In certain embodiments, the size and density of thepores 3508 within the first inner layer 3512 and the pores 3509 withinthe second inner layer 3513 can be selected so as to provide a desiredresult described herein.

In various embodiments, referring again to FIGS. 125 and 126, the outerlayer 3511, the first inner layer 3512, and/or the second inner layer3513 can be comprised of a bioabsorbable material. In at least oneembodiment, the first inner layer 3512 can be comprised of a firstbioabsorbable material, the second inner layer 3513 can be comprised ofa second bioabsorbable material, and the outer layer 3511 can becomprised of a third bioabsorbable material, wherein the firstbioabsorbable material, the second bioabsorbable material, and/or thethird bioabsorbable material can be comprised of different materials. Incertain embodiments, the first bioabsorbable material can be bioabsorbedat a first rate, the second bioabsorbable material can be bioabsorbed ata second rate, and the third bioabsorbable material can be bioabsorbedat a third rate, wherein the first rate, the second rate, and/or thethird rate can be different. In at least one such embodiment, when amaterial is bioabsorbed at a particular rate, such a rate can be definedas the amount of material mass that is absorbed by a patient's body overa unit of time. As it is known, the bodies of different patients mayabsorb different materials at different rates and, thus, such rates maybe expressed as average rates in order to account for such variability.In any event, a faster rate may be a rate in which more mass isbioabsorbed for a unit of time than a slower rate. In variousembodiments, referring again to FIGS. 125 and 126, the first inner layer3512 and/or the second inner layer 3513 can be comprised of a materialwhich bioabsorbs faster than the material comprising the outer layer3511. In at least one such embodiment, the first inner layer 3512 and/orthe second inner layer 3513 can be comprised of a bioabsorbable foam,tissue sealant, and/or hemostatic material, such as oxidized regeneratedcellulose (ORC), for example, and the outer layer 3511 can be comprisedof a buttress material and/or plastic material, such as polyglycolicacid (PGA) which is marketed under the trade name Vicryl, polylacticacid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA),poliglecaprone 25 (PGCL) which is marketed under the trade nameMonocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS,PHA, PGCL and/or PCL, for example. In such embodiments, the first innerlayer 3512 and/or the second inner layer 3513 can immediately treat thetissue and can reduce bleeding from the tissue, for example, wherein theouter layer 3514 can provide longer-term structural support and can bebioabsorbed at a slower rate.

Owing to the slower rate of bioabsorbability of the outer layer 3511,further to the above, the outer layer 3511 can buttress or structurallyreinforce the tissue within the staple line as it heals. In certainembodiments, one of the first inner layer 3512 and the second innerlayer 3513 can be comprised of a material which can be bioabsorbedfaster than the other such that, in at least one embodiment, one of thelayers can provide an initial release of a therapeutic material and theother layer can provide a sustained release of the same therapeuticmaterial and/or a different therapeutic material. In at least one suchembodiment, the rate in which a therapeutic material can be releasedfrom a layer 3512, 3513 can be a function of the bioabsorbability of thesubstrate layer in which the medicament is absorbed or dispersed. Forexample, in at least one embodiment, the substrate comprising the firstinner layer 3512 can be bioabsorbed faster than the substrate comprisingthe second inner layer 3513 and, as a result, a medicament can berelease from the first inner layer 3512 faster than the second innerlayer 3513, for example. In various embodiments, as described herein,one or more of the layers 3511, 3512, and 3513 of the cartridge body3510 can be adhered to one another by at least one adhesive, such asfibrin and/or protein hydrogel, for example. In certain embodiments, theadhesive can be water soluble and can be configured to release theconnection between the layers as the staple cartridge 3500 is beingimplanted and/or some time thereafter. In at least one such embodiment,the adhesive can be configured to bioabsorb faster than the outer layer3511, the first inner layer 3512, and/or the second inner layer 3513.

In various embodiments, referring now to FIGS. 127 and 128, a staplecartridge, such as staple cartridge 3600, for example, can comprise acartridge body 3610 including a compressible first layer 3611, a secondlayer 3612 attached to the first layer 3611, and a removablecompressible layer 3613 attached to the second layer 3612. In at leastone such embodiment, the first layer 3611 can be comprised of acompressible foam material, the second layer 3612 can comprise alaminate material adhered to the first layer 3611 utilizing one or moreadhesives, and the third layer 3613 can comprise a compressible foammaterial removably adhered to the second layer 3612 utilizing one ormore adhesives, for example. In various embodiments, the staplecartridge 3600 can further comprise a plurality of staples, such asstaples 3620, for example, positioned in the cartridge body 3610. In atleast one such embodiment, each staple 3620 can comprise a base 3622positioned in the third layer 3613 and one or more deformable legs 3621extending upwardly from the base 3622 through the second layer 3612 andinto the first layer 3611, for example. In use, further to the above,the top surface 3619 of the staple cartridge body 3610 can be pusheddownwardly by an anvil until the staple legs 3621 penetrate through thetop surface 3619 and the targeted tissue and contact the anvil. Afterthe staple legs 3621 have been sufficiently deformed, the anvil can bemoved away from the staple cartridge 3600 such that the compressiblelayers thereof can at least partially re-expand. In variouscircumstances, the insertion of the staples through the tissue can causethe tissue to bleed. In at least one embodiment, the third layer 3613can be comprised of an absorbent material, such as protein hydrogel, forexample, which can draw blood away from the stapled tissue. In additionto or in lieu of the above, the third layer 3613 can be comprised of ahemostatic material and/or tissue sealant, such as freeze-dried thrombinand/or fibrin, for example, which can be configured to reduce thebleeding from the tissue. In certain embodiments, the third layer 3613may provide a structural support to the first layer 3611 and the secondlayer 3612 wherein the third layer 3613 may be comprised of abioabsorbable material and/or a non-bioabsorbable material. In anyevent, in various embodiments, the third layer 3613 can be detached fromthe second layer 3612 after the staple cartridge 3610 has beenimplanted. In embodiments where the third layer 3613 comprises animplantable-quality material, the surgeon can elect whether to removethe third layer 3613 of the cartridge body 3610. In at least oneembodiment, the third layer 3613 can be configured to be removed fromthe second layer 3612 in one piece.

In various embodiments, the first layer 3611 can be comprised of a firstfoam material and the third layer 3613 can be comprised of a second foammaterial which can be different than the first foam material. In atleast one embodiment, the first foam material can have a first densityand the second foam material can have a second density wherein the firstdensity can be different than the second density. In at least one suchembodiment, the second density can be higher than the first densitywherein, as a result, the third layer 3613 may be less compressible, orhave a lower compression rate, than the first layer 3611. In at leastone alternative embodiment, the first density can be higher than thesecond density wherein, as a result, the first layer 3611 may be lesscompressible, or have a lower compression rate, than the third layer3613. In various embodiments, referring now to FIGS. 129 and 130, astaple cartridge 3700, similar to the staple cartridge 3600, cancomprise a cartridge body 3710 comprising a first compressible foamlayer 3711, a second layer 3712 attached to the first layer 3711, and adetachable third compressible foam layer 3713 removably attached to thesecond layer 3712. In at least one such embodiment, the third layer 3713can comprise a plurality of staple receiving slots, or cut-outs, 3709which can each be configured to receive at least a portion of a staple3620, such as a staple base 3622, for example, therein. In certainembodiments, the staples 3620 can be configured to slide within thestaple receiving slots 3709 or, stated another way, the third layer 3713can be configured to slide relative to the staples 3620 when the staplecartridge 3700 is positioned against the targeted tissue and compressedby an anvil, for example. In at least one embodiment, the receivingslots 3709 can be configured such that there is clearance between thestaples 3620 and the side walls of the receiving slots 3709. In at leastone such embodiment, as a result of the above, the staples 3620 may notcapture a portion of the third layer 3713 therein when the staples 3620are deformed, as illustrated in FIGS. 129 and 130. In certain otherembodiments, the ends of the staple receiving slots 3709 adjacent to thesecond layer 3712 can be closed by a portion of the third layer 3713and, as a result, at least a portion of the third layer 3713 can becaptured within the staples 3620 when they are deformed. In any event,the third layer 3713 can comprise one or more perforations and/or scoremarks 3708, for example, which can be configured to permit the thirdlayer 3713 to be removed from the second layer 3712 in two or morepieces as illustrated in FIG. 129. In FIG. 129, one of the pieces of thethird layer 3713 is illustrated as being removed by a tool 3755. Invarious embodiments, the perforations 3708 can be arranged along a linepositioned intermediate a first row of staples and a second row ofstaples.

In various embodiments, referring again to FIGS. 129 and 130, the bases3622 of the staples 3620 can be positioned within the receiving slots3709 wherein, in at least one embodiment, the side walls of thereceiving slots 3709 can be configured to contact and releasable retainthe staple legs 3621 in position. In certain embodiments, although notillustrated, the third layer 3713 can comprise an elongated slotsurrounding all of the staples within a staple line. In at least onesuch embodiment, a staple cartridge comprising four staple rows, forexample, can comprise an elongate slot aligned with each staple row inthe bottom layer of the staple cartridge. Further to the above, at leasta portion of the staple cartridge 3600 and/or the staple cartridge 3700can be implanted within a patient and at least a portion of the staplecartridge can be removable from the patient. In at least one embodiment,referring again to FIGS. 129 and 130, the first layer 3711 and thesecond layer 3712 can be captured within the staples 3620 and can beimplanted with the staples 3620, whereas the third layer 3713 can beoptionally removed or detached from the staple cartridge 3700. Invarious circumstances, the removal of a portion of the implanted staplecartridge can reduce the amount of material that the patient's body hasto reabsorb which can provide various therapeutic benefits. In the eventthat a portion of a staple cartridge is detached and removed, such as bya laparoscopic tool 3755, for example, the detached staple cartridgeportion can be removed from the surgical site through a trocar, such asa trocar having a 5 mm aperture, for example. In certain embodiments, acartridge body can comprise more than one layer that can be removed. Forexample, the cartridge body 3710 can comprise a fourth layer wherein thethird layer of 3713 of the cartridge body 3710 can be comprised of ahemostatic material and the fourth layer can be comprised of a supportlayer. In at least one such embodiment, a surgeon can remove the supportlayer and then elect whether to remove the hemostatic layer, forexample.

In various embodiments, referring now to FIG. 131, a staple cartridge,such as staple cartridge 3800, for example, can comprise a cartridgebody 3810 including an outer layer 3811 and an inner layer 3812. Theinner layer 3812 can be comprised of a compressible foam material andthe outer layer 3811 can be at leas partially wrapped around the innerlayer 3812. In at least one embodiment, the outer layer 3811 cancomprise a first portion 3811 a configured to be positioned on a firstside of the inner layer 3812 and a second portion 3811 b configured tobe positioned on a second side of the inner layer 3812 wherein the firstportion 3811 a and the second portion 3811 b can be connected by aflexible hinge, such as hinge 3809, for example. In at least one suchembodiment, at least one adhesive, such as fibrin and/or proteinhydrogel, for example, can be applied to the first side and/or thesecond side of the inner layer 3812 in order to secure the portions ofthe outer layer 3811 thereto. In various embodiments, the outer layer3811 can comprise one or more fastening members extending therefrom. Inat least one such embodiment, the outer layer 3811 can comprise aplurality of deformable legs 3821 extending from one side of the outerlayer 3811 which can be seated in the compressible inner layer 3812. Inat least one such embodiment, the legs 3821 may not protrude from thesecond side of the inner layer 3812 while, in at least one alternativeembodiment, the legs 3821 may at least partially protrude from the innerlayer 3812. When the compressible cartridge body 3810 is compressed, inuse, the legs 3821 can be configured to pierce the inner layer 3812 andthe second portion 3811 b of the outer layer 3811. In certainembodiments, the second portion 3811 b of the outer layer 3811 cancomprise apertures, such as apertures 3808, for example defined thereinwhich can be configured to receive the staple legs 3821. In certainembodiments, at least portions of the staple cartridge 3800 can comprisea knife slot 3803 which can be configured to slidably receive a cuttingmember therein. In at least one such embodiment, the knife slot 3803 maynot extend entirely through the thickness of the cartridge body 3810and, as a result, the cutting member may incise the cartridge body 3810as it is moved relative thereto.

In various embodiments, referring now to FIG. 132, a staple cartridge3900 can comprise, similar to staple cartridge 3800, a cartridge body3910 including an inner layer 3812 and an outer layer 3811, wherein theouter layer 3811 can comprise a first portion 3811 a positioned adjacentto the first side of the inner layer 3812 and a second portion 3811 bpositioned adjacent to the second side of the inner layer 3812. In atleast one embodiment, similar to the above, the outer layer 3811 cancomprise one or more fastening members extending therefrom. In at leastone such embodiment, the outer layer 3811 can comprise a plurality ofdeformable legs 3921 extending from one side of the outer layer 3811which can be seated in the compressible inner layer 3812. In certainembodiments, each deformable leg 3921 can comprise at least one hook orbarb 3923 protruding therefrom which can be configured to engage thesecond portion 3811 b of the outer layer 3811 and, as a result, retainthe outer layer 3811 to the inner layer 3812. In at least one suchembodiment, the barbs 3923 can be configured to protrude from the secondside of the inner layer 3812 and extend through the apertures 3808 inthe second portion 3811 b of the outer layer 3811 such that the barbs3923 can engage the outside surface of the outer layer 3811 and lock theouter layer 3811 to the inner layer 3812. In order to construct thestaple cartridge 3900, the inner layer 3812 may be at least partiallycompressed in order to cause the barbs to protrude therefrom and enterinto the apertures 3808. In at least one such embodiment, the staplecartridge 3900 can be at least partially pre-compressed when it isinserted into a staple cartridge, for example. In certain embodiments,further to the above, at least a portion of the legs 3921 can beembedded within the first portion 3811 a of the outer layer 3811wherein, in at least one embodiment, the outer layer 3811 can becomprised of a plastic material, such as polydioxanone (PDS) and/orpolyglycolic acid (PGA), for example, and the plastic material can beovermolded around at least a portion of the legs 3921.

In various embodiments, referring now to FIGS. 133-137, a staplecartridge, such as staple cartridge 4000, for example, can comprise acartridge body 4010 including a compressible first layer 4011 and asecond layer 4012 and, in addition, a plurality of staples 4020positioned within the cartridge body 4010. In certain embodiments,referring to FIG. 135, each staple 4020 can comprise a base 4022 and atleast one deformable leg 4023 extending from the base 4022. In at leastone embodiment, referring to FIG. 133, the staple cartridge 4000 can bepositioned between a staple cartridge channel 4030 and an anvil 4040 ofan end effector of a surgical stapler wherein the second layer 4012 ofthe cartridge body 4010 and/or the bases 4022 of the staples 4020 can bepositioned against the staple cartridge channel 4030. In variousembodiments, referring now to FIG. 134, the second layer 4012 cancomprise a layer of pledgets 4060 interconnected to one another by apledget support frame 4061. In at least one such embodiment, thepledgets 4060 and the pledget support frame 4061 can be comprised of amolded plastic material, such as polyglycolic acid (PGA), for example.Each pledget 4060 can comprise one or more apertures or slots 4062 whichcan be configured to receive a staple leg 4021 extending therethrough asillustrated in FIGS. 135 and 136. Each pledget 4060 can further comprisea receiving slot 4063 defined therein which can be configured to receivea base 4022 of a staple 4020. In various embodiments, referring again toFIG. 134, the pledgets 4060 and/or pledget support frame 4061 cancomprise a plurality of score marks, perforations, or the like which canbe configured to allow the pledgets 4060 to become detached from thepledget support frame 4061 at a desired location. Similarly, referringto FIG. 136, one or more pledgets 4060 can be connected to one anotheralong a line comprising perforations and/or score marks 4064, forexample. In use, the compressible foam layer 4011 can be positionedagainst the targeted tissue T and the cartridge body 4010 can becompressed by the anvil 4040 such that the anvil 4040 can deform thestaples 4020. When the staples 4020 are deformed, the staple legs 4021of each staple 4020 can capture the tissue T, a portion of the firstlayer 4011, and a pledget 4060 within the deformed staple. When thestaple cartridge channel 4030 is moved away from the implanted staplecartridge 4060, for example, the pledget support frame 4061 can bedetached from the pledgets 4060 and/or the pledgets 4060 can be detachedfrom one another. In certain circumstances, the pledgets 4060 can bedetached from the frame 4061 and/or each other when the staples 4020 arebeing deformed by the anvil 4040 as described above.

In various embodiments described herein, the staples of a staplecartridge can be fully formed by an anvil when the anvil is moved into aclosed position. In various other embodiments, referring now to FIGS.138-141, the staples of a staple cartridge, such as staple cartridge4100, for example, can be deformed by an anvil when the anvil is movedinto a closed position and, in addition, by a staple driver system whichmoves the staples toward the closed anvil. The staple cartridge 4100 cancomprise a compressible cartridge body 4110 which can be comprised of afoam material, for example, and a plurality of staples 4120 at leastpartially positioned within the compressible cartridge body 4110. Invarious embodiments, the staple driver system can comprise a driverholder 4160, a plurality of staple drivers 4162 positioned within thedriver holder 4160, and a staple cartridge pan 4180 which can beconfigured to retain the staple drivers 4162 in the driver holder 4160.In at least one such embodiment, the staple drivers 4162 can bepositioned within one or more slots 4163 in the driver holder 4160wherein the sidewalls of the slots 4163 can assist in guiding the stapledrivers 4162 upwardly toward the anvil. In various embodiments, thestaples 4120 can be supported within the slots 4163 by the stapledrivers 4162 wherein, in at least one embodiment, the staples 4120 canbe entirely positioned in the slots 4163 when the staples 4120 and thestaple drivers 4162 are in their unfired positions. In certain otherembodiments, at least a portion of the staples 4120 can extend upwardlythrough the open ends 4161 of slots 4163 when the staples 4120 andstaple drivers 4162 are in their unfired positions. In at least one suchembodiment, referring primarily now to FIG. 139, the bases of thestaples 4120 can be positioned within the driver holder 4160 and thetips of the staples 4120 can be embedded within the compressiblecartridge body 4110. In certain embodiments, approximately one-third ofthe height of the staples 4120 can be positioned within the driverholder 4160 and approximately two-thirds of the height of the staples4120 can be positioned within the cartridge body 4110. In at least oneembodiment, referring to FIG. 138A, the staple cartridge 4100 canfurther comprise a water impermeable wrap or membrane 4111 surroundingthe cartridge body 4110 and the driver holder 4160, for example.

In use, the staple cartridge 4100 can be positioned within a staplecartridge channel, for example, and the anvil can be moved toward thestaple cartridge 4100 into a closed position. In various embodiments,the anvil can contact and compress the compressible cartridge body 4110when the anvil is moved into its closed position. In certainembodiments, the anvil may not contact the staples 4120 when the anvilis in its closed position. In certain other embodiments, the anvil maycontact the legs of the staples 4120 and at least partially deform thestaples 4120 when the anvil is moved into its closed position. In eitherevent, the staple cartridge 4100 can further comprise one or more sleds4170 which can be advanced longitudinally within the staple cartridge4100 such that the sleds 4170 can sequentially engage the staple drivers4162 and move the staple drivers 4162 and the staples 4120 toward theanvil. In various embodiments, the sleds 4170 can slide between thestaple cartridge pan 4180 and the staple drivers 4162. In embodimentswhere the closure of the anvil has started the forming process of thestaples 4120, the upward movement of the staples 4120 toward the anvilcan complete the forming process and deform the staples 4120 to theirfully formed, or at least desired, height. In embodiments where theclosure of the anvil has not deformed the staples 4120, the upwardmovement of the staples 4120 toward the anvil can initiate and completethe forming process and deform the staples 4120 to their fully formed,or at least desired, height. In various embodiments, the sleds 4170 canbe advanced from a proximal end of the staple cartridge 4100 to a distalend of the staple cartridge 4100 such that the staples 4120 positionedin the proximal end of the staple cartridge 4100 are fully formed beforethe staples 4120 positioned in the distal end of the staple cartridge4100 are fully formed. In at least one embodiment, referring to FIG.140, the sleds 4170 can each comprise at least one angled or inclinedsurface 4711 which can be configured to slide underneath the stapledrivers 4162 and lift the staple drivers 4162 as illustrated in FIG.141.

In various embodiments, further to the above, the staples 4120 can beformed in order to capture at least a portion of the tissue T and atleast a portion of the compressible cartridge body 4110 of the staplecartridge 4100 therein. After the staples 4120 have been formed, theanvil and the staple cartridge channel 4130 of the surgical stapler canbe moved away from the implanted staple cartridge 4100. In variouscircumstances, the cartridge pan 4180 can be fixedly engaged with thestaple cartridge channel 4130 wherein, as a result, the cartridge pan4180 can become detached from the compressible cartridge body 4110 asthe staple cartridge channel 4130 is pulled away from the implantedcartridge body 4110. In various embodiments, referring again to FIG.138, the cartridge pan 4180 can comprise opposing side walls 4181between which the cartridge body 4110 can be removably positioned. In atleast one such embodiment, the compressible cartridge body 4110 can becompressed between the side walls 4181 such that the cartridge body 4110can be removably retained therebetween during use and releasablydisengaged from the cartridge pan 4180 as the cartridge pan 4180 ispulled away. In at least one such embodiment, the driver holder 4160 canbe connected to the cartridge pan 4180 such that the driver holder 4160,the drivers 4162, and/or the sleds 4170 can remain in the cartridge pan4180 when the cartridge pan 4180 is removed from the surgical site. Incertain other embodiments, the drivers 4162 can be ejected from thedriver holder 4160 and left within the surgical site. In at least onesuch embodiment, the drivers 4162 can be comprised of a bioabsorbablematerial, such as polyglycolic acid (PGA) which is marketed under thetrade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS),polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketedunder the trade name Monocryl, polycaprolactone (PCL), and/or acomposite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example. Invarious embodiments, the drivers 4162 can be attached to the staples4120 such that the drivers 4162 are deployed with the staples 4120. Inat least one such embodiment, each driver 4162 can comprise a troughconfigured to receive the bases of the staples 4120, for example,wherein, in at least one embodiment, the troughs can be configured toreceive the staple bases in a press-fit and/or snap-fit manner.

In certain embodiments, further to the above, the driver holder 4160and/or the sleds 4170 can be ejected from the cartridge pan 4180. In atleast one such embodiment, the sleds 4170 can slide between thecartridge pan 4180 and the driver holder 4160 such that, as the sleds4170 are advanced in order to drive the staple drivers 4162 and staples4120 upwardly, the sleds 4170 can move the driver holder 4160 upwardlyout of the cartridge pan 4180 as well. In at least one such embodiment,the driver holder 4160 and/or the sleds 4170 can be comprised of abioabsorbable material, such as polyglycolic acid (PGA) which ismarketed under the trade name Vicryl, polylactic acid (PLA or PLLA),polydioxanone (PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25(PGCL) which is marketed under the trade name Monocryl, polycaprolactone(PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, forexample. In various embodiments, the sleds 4170 can be integrally formedand/or attached to a drive bar, or cutting member, which pushes thesleds 4170 through the staple cartridge 4100. In such embodiments, thesleds 4170 may not be ejected from the cartridge pan 4180 and may remainwith the surgical stapler while, in other embodiments in which the sleds4170 are not attached to the drive bar, the sleds 4170 may be left inthe surgical site. In any event, further to the above, thecompressibility of the cartridge body 4110 can allow thicker staplecartridges to be used within an end effector of a surgical stapler asthe cartridge body 4110 can compress, or shrink, when the anvil of thestapler is closed. In certain embodiments, as a result of the staplesbeing at least partially deformed upon the closure of the anvil, tallerstaples, such as staples having an approximately 0.18″ staple height,for example, could be used, wherein approximately 0.12″ of the stapleheight can be positioned within the compressible layer 4110 and whereinthe compressible layer 4110 can have an uncompressed height ofapproximately 0.14″, for example.

In various embodiments, referring now to FIGS. 142-145, a staplecartridge, such as staple cartridge 4200, for example, can comprise acompressible cartridge body 4210, a plurality of staples 4220 positionedtherein, and a plurality of flexible lateral support members 4234. Invarious embodiments, referring now to FIG. 143, the staple cartridge4200 can be positioned intermediate an anvil 4240 and a staple cartridgechannel 4230 wherein, in at least one embodiment, the lateral supportmembers 4234 can be attached to the staple cartridge channel 4230. Whenthe anvil 4240 is moved downwardly to compress the cartridge body 4210and at least partially deform the staples 4220, as illustrated in FIG.144, the side portions of the cartridge body 4210 can bulge laterallyand push the lateral support members 4234 outwardly. In at least onesuch embodiment, the lateral support members 4234 can be attached to thecartridge body 4210 and, when the cartridge body 4210 bulges laterallyas described above, the lateral support members 4234 can detach from thecartridge body 4210 as illustrated in FIG. 144. In at least oneembodiment, the lateral support members 4234 can be adhered to thecartridge body 4210 utilizing at least one adhesive, such as fibrinand/or protein hydrogel, for example. Similar to the above, the closingof the anvil 4240 may only partially deform the staples 4220, whereinthe formation of the staples 4220 can be completed by the advancement ofone or more sleds 4270 through the staple cartridge 4200 as illustratedin FIG. 145. In various embodiments, referring now to FIGS. 147 and 148,the sleds 4270 can be advanced from a proximal end of the staplecartridge 4200 to a distal end of the staple cartridge 4200 by a cuttingmember 4280. In at least one such embodiment, the cutting member 4280can comprise a cutting element, or knife, 4283, which can be advancedthrough the tissue T and/or the compressible cartridge body 4210. Incertain embodiments, the cutting member 4280 can comprise cammingmembers 4282 which can travel along the outside surfaces of the jaws4230 and 4240 and move or hold the jaws in position. In variousembodiments, as a result of the above, the staples 4220 can be formedinto their final shapes at the same time, or at least substantially thesame time, as the tissue T is incised. In at least one such embodiment,the sleds 4270 can be positioned distally with respect to the knife 4283such that the tissue T is only incised when the proceeding portion ofthe tissue has been fully stapled, for example.

In various embodiments, referring again to FIGS. 147 and 148, the sleds4270 can comprise separate slidable members which are advanced togetherby the cutting member 4280. In at least one such embodiment, the sleds4270 can be contained within the staple cartridge 4200 and the cuttingmember 4280 can be advanced into the staple cartridge 4200 by a firingbar 4281 such that the cutting member 4280 engages the sleds 4270 andadvances the sleds 4270 distally. In certain embodiments, the sleds 4270can be connected to one another. In either event, each sled 4270 cancomprise an angled surface, or cam, 4271 which can be configured to liftthe staples 4220 aligned within a staple row. In certain embodiments,the angled surfaces 4271 can be integrally formed with the cuttingmember 4280. In at least one embodiment, referring again to FIGS. 147and 148, each staple 4200 can comprise a base, at least one deformablemember extending from the base, and a crown 4229 overmolded onto and/orpositioned around at least a portion of the base and/or the deformablemembers of the staple 4200. In various embodiments, such crowns 4229 canbe configured to be driven directly by a sled 4270, for example. Moreparticularly, in at least one embodiment, the crowns 4229 of staples4220 can be configured such that the angled surfaces 4271 of the sleds4270 can slide underneath and directly contact the crowns 4229 without astaple driver positioned therebetween. In such embodiments, each crown4229 can comprise at least one co-operating angled or inclined surfacewhich can be engaged by an angled surface 4271 of the sleds 4270 suchthat the co-operating angled surfaces can drive the staples 4220upwardly when the sleds 4270 are slid underneath the staples 4220.

In various embodiments, referring now to FIG. 146, a staple cartridge,such as staple cartridge 4300, for example, can comprise a compressiblebody 4310 and a plurality of staples 4320 positioned within thecompressible body 4310. Similar to the above, the staple cartridge 4300can comprise flexible lateral supports 4334 which can be attached to astaple cartridge channel and/or adhered to the compressible body 4310.In addition to the above, the flexible lateral supports 4334 can beconnected together by one or more struts, or connection members, 4335which can be configured to hold the lateral supports 4334 together. Inuse, the connection members 4335 can be configured to prevent, or atleast inhibit, the lateral supports 4334 from becoming prematurelydetached from the cartridge body 4310. In certain embodiments, theconnection members 4335 can be configured to hold the lateral supports4334 together after the staple cartridge 4300 has been compressed by ananvil. In such embodiments, the lateral supports 4334 can resist thelateral bulging, or displacement, of the lateral portions of thecartridge body 4310. In certain embodiments, a cutting member, such ascutting member 4280, for example, can be configured to transect theconnection members 4335 as the cutting member 4280 is moved distallywithin the cartridge body 4310. In at least one such embodiment, thecutting member 4280 can be configured to push one or more sleds, such assleds 4270, for example, distally in order to form the staples 4320against an anvil. The sleds 4270 can lead the cutting edge 4283 suchthat the cutting member 4280 does not transect a connection member 4335until the staples 4320 adjacent to that connection member 4335 have beenfully formed, or at least formed to a desired height. In variouscircumstances, the connection members 4335, in co-operation with thelateral supports 4334, can prevent, or at least reduce, the lateralmovement of the compressible cartridge body 4310 and, concurrently,prevent, or at least reduce, the lateral movement of the staples 4320positioned within the cartridge body 4310. In such circumstances, theconnection members 4335 can hold the staples 4320 in position untilafter they are deformed and the connection members 4335 can bethereafter cut to release the lateral portions of the cartridge body4310. As mentioned above, the lateral supports 4334 can be connected tothe staple cartridge channel and, as a result, can be removed from thesurgical site with the staple cartridge channel after the staplecartridge 4300 has been implanted. In certain embodiments, the lateralsupports 4334 can be comprised of an implantable material and can beleft within a surgical site. In at least one embodiment, the connectionmembers 4335 can be positioned intermediate the cartridge body 4310 andthe tissue T and, after the connection members 4335 have been detachedfrom the lateral supports 4334, the connections members 4335 can remainimplanted in the patient. In at least one such embodiment, theconnection members 4335 can be comprised of an implantable material and,in certain embodiments, the connection members 4335 can be comprised ofthe same material as the lateral supports 4334, for example. In variousembodiments, the connection members 4335 and/or lateral supports 4334can be comprised of a flexible bioabsorbable material such aspolyglycolic acid (PGA) which is marketed under the trade name Vicryl,polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate(PHA), poliglecaprone 25 (PGCL) which is marketed under the trade nameMonocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS,PHA, PGCL and/or PCL, for example. In various embodiments, a connectionmember can comprise a sheet of material connecting the lateral supports4334. In certain embodiments, a staple cartridge can comprise connectionmembers extending across the top surface of the cartridge body 4310 and,in addition, connection members extending around the bottom surface ofthe cartridge body 4310.

In various embodiments, referring now to FIG. 149, a staple cartridgecan comprise staples, such as staples 4420, for example, which cancomprise a wire portion inserted into a crown portion. In at least oneembodiment, the wire portion can be comprised of metal, such as titaniumand/or stainless steel, for example, and/or plastic, such aspolydioxanone (PDS) and/or polyglycolic acid (PGA), for example. In atleast one embodiment, the crown portion can be comprised of metal, suchas titanium and/or stainless steel, for example, and/or plastic, such aspolydioxanone (PDS) and/or polyglycolic acid (PGA), for example. Incertain embodiments, the wire portion of each staple 4420 can comprise abase 4422 and deformable legs 4421 extending from the base 4422 whereinthe crown portion of each staple 4420 can comprise a crown 4429 whichcan be configured to receive at least a portion of a base 4422 therein.In order to assemble the portions of each staple 4420, referring now toFIGS. 150A-150C, the legs 4421 of the wire portion can be inserted intoan opening 4426 in a crown 4429 wherein the opening 4426 can beconfigured to guide the legs 4421 into a base chamber 4427. The wireportion can be further inserted into the crown 4429 such that the legs4421 exit the base chamber 4427 and the base 4422 of the wire portionenters into the base chamber 4427. In at least one such embodiment, thebase chamber 4427 can be configured such that the wire portion isrotated within the crown 4429 as the base 4422 enters into the basechamber 4427 such that the staple legs 4421 are pointed in an upward, orat least substantially upward, direction. In various embodiments,referring again to FIG. 149, the crown 4429 can comprise exit holes 4425which can be configured to receive the staple legs 4421 therein.

In various embodiments, further to the above, a surgical stapler cancomprise a sled 4470 configured to transverse the staple cartridge 4400and staple cartridge channel 4430 and move the staples 4420 containedwithin the cartridge body 4410 toward an anvil. In variouscircumstances, the sled 4470 can be moved from a proximal end of thestaple cartridge channel 4430 to a distal end of the cartridge channel4430 in order to implant the cartridge body 4410 and the staples 4420.In certain circumstances, the sled 4470 can be retracted or returned tothe proximal end of the cartridge channel 4430 and another staplecartridge 4400 can be inserted into the cartridge channel 4430. Once thenew staple cartridge 4400 has been positioned within the cartridgechannel 4430, the sled 4470 can be advanced distally once again. Invarious embodiments, the surgical stapler may comprise one or morelock-out features which can prevent the sled 4470 from being advanceddistally once again without a new staple cartridge 4400 being positionedwithin the cartridge channel 4430. In at least one such embodiment,referring again to FIG. 149, the staple cartridge channel 4430 cancomprise a lock-out shoulder 4439 which can be configured to prevent, orat least limit, the distal movement of the sled 4470. More particularly,the sled 4470 can be configured to abut the shoulder 4439 unless thesled 4470 is at least partially lifted upwardly over the shoulder 4439by a lift feature 4428, for example, extending between the proximal-moststaples 4420 within a staple cartridge 4400. Stated another way, absentthe presence of the proximal-most staples 4420 in a new staple cartridge4400, the sled 4470 cannot be advanced. Thus, when an expended staplecartridge 4400 is present within the cartridge channel 4430, or nostaple cartridge 4400 is present in the cartridge channel 4430 at all,the sled 4470 cannot be advanced within the cartridge channel 4430.

Further to the above, referring now to FIG. 151, a staple cartridge,such as staple cartridge 4500, for example, can be positioned within astaple cartridge channel 4530 and can comprise a compressible cartridgebody 4510, a plurality of staples 4520 positioned within the cartridgebody 4510, and a cartridge pan, or retainer, 4580. In variousembodiments, the compressible cartridge body 4510 can comprise an outerlayer 4511 and an inner layer 4512 wherein, in at least one embodiment,the outer layer 4511 can sealingly enclose the inner layer 4512. In atleast one such embodiment, the outer layer 4511 can extend between theinner layer 4512 and the cartridge pan 4580. In certain otherembodiments, the outer layer 4511 may only partially surround the innerlayer 4512 and, in at least one such embodiment, the outer layer 4511and the cartridge pan 4580 can co-operate to encompass, or at leastsubstantially encompass, the inner layer 4512. In various embodiments,further to the above, the staples 4520 can be supported by the cartridgepan 4580 wherein the cartridge pan 4580 can comprise one or more staplesupport channels configured to support the staples 4520. In certainembodiments, the cartridge pan 4580 can be attached to the cartridgebody 4510 wherein, in at least one such embodiment, the cartridge body4510 can be compressed laterally between opposing side walls of thecartridge pan 4580. In various embodiments, the side walls of thecartridge pan 4580 can support the cartridge body 4510 laterally and, inat least one such embodiment, the cartridge pan 4580 can comprise one ormore walls, or fins, 4582 extending upwardly from the bottom support4583 into the cartridge body 4510. In at least one such embodiment, thecartridge body 4510 can comprise one or more slots, or channels, thereinwhich can be configured to receive and/or interlock with the walls 4582.In various embodiments, the walls 4582 can extend partially, or almostentirely, through the cartridge body 4510. In at least one suchembodiment, the walls 4582 can extend longitudinally through the staplecartridge 4500 between a first row of staples 4520 and a second row ofstaples 4520.

In various embodiments, the cartridge body 4510 and/or the cartridge pan4580 can comprise co-operating retention features which can provide asnap-fit between the cartridge pan 4580 and the cartridge body 4510. Incertain embodiments, the staple cartridge 4500 can be positioned withinthe cartridge channel 4530 such that the cartridge pan 4580 ispositioned against and/or attached to the cartridge channel 4530. In atleast one embodiment, the cartridge pan 4580 can be detachably coupledto the cartridge channel 4530 such that, after the staple cartridge 4500has been compressed by the anvil 4540 and the staples 4520 have beendeformed, the cartridge pan 4580 can detach from the cartridge channel4530 and can be implanted with the cartridge body 4510. In at least onesuch embodiment, the cartridge pan 4580 can be comprised of abioabsorbable material such as polyglycolic acid (PGA) which is marketedunder the trade name Vicryl, polylactic acid (PLA or PLLA),polydioxanone (PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25(PGCL) which is marketed under the trade name Monocryl, polycaprolactone(PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, forexample. In certain embodiments, a surgical stapler can further comprisea firing mechanism and/or driver which can be slid intermediate thestaple cartridge channel 4530 and a bottom drive surface on thecartridge pan 4580 which can be configured to lift or eject thecartridge pan 4580 from the cartridge channel 4530. In certainembodiments, the cartridge body 4510 can be detachably coupled to thecartridge pan 4580 such that, after the staple cartridge 4500 has beencompressed by the anvil 4540 and the staples 4520 have been deformed,the cartridge body 4510 can detach from the cartridge pan 4580. In atleast one such embodiment, the cartridge pan 4580 can remain fixedlyengaged with the cartridge channel 4530 such that the cartridge pan 4580is removed from the surgical site with the cartridge channel 4530. Incertain embodiments, a surgical stapler can further comprise a firingmechanism and/or driver which can be slid intermediate the staplecartridge pan 4580 and a bottom drive surface on the cartridge body 4510which can be configured to lift or eject the cartridge body 4510 fromthe cartridge pan 4580. In at least one such embodiment, the staplecartridge 4500 can further comprise staple drivers positionedintermediate the cartridge pan 4580 and the staples 4520 such that, asthe firing mechanism is slid distally, the staple drivers and thestaples 4520 can be driven upwardly toward the anvil. In at least onesuch embodiment, the staple drivers can be at least partially embeddedwithin the compressible cartridge body 4510.

In various embodiments, similar to the above, the staple cartridge 4500can comprise a lock-out feature which can be configured to prevent, orat least limit, the distal movement of a cutting member unless a unfiredstaple cartridge 4500 has been positioned within the staple cartridgechannel 4530. In certain embodiments, the staple cartridge pan 4580 cancomprise a surface which lifts the cutting member upwardly and over alocking surface within the staple cartridge channel 4530, for example.In the event that a staple cartridge 4500 comprising a cartridge pan4580 is not present in the cartridge channel 4530, the cutting membercannot be advanced. In at least one embodiment, the proximal-moststaples, and/or any other suitable staples, within a staple cartridge4500 can comprise a lifting surface which can sufficiently lift thecutting member over the locking surface. In addition to or in lieu ofthe above, various portions of the staple cartridge 4500 can becomprised of materials having different colors. In such embodiments, asurgeon may be able to visually identify when an unfired and/or firedstaple cartridge is present in the staple cartridge channel 4530. In atleast one such embodiment, the outer layer 4511 of the cartridge body4510 may have a first color, the cartridge pan 4580 may have a secondcolor, and the staple cartridge channel 4530 may have a third color. Inthe event that the surgeon sees the first color, the surgeon may knowthat an unfired cartridge 4500 is present in the staple cartridgechannel 4530; in the event that the surgeon sees the second color, thesurgeon may know that a fired cartridge 4500 is present in the staplecartridge channel 4530 and that the remaining cartridge pan 4580 needsto be removed; and in the event that the surgeon sees the third color,the surgeon may know that no portion of a staple cartridge 4500 remainswithin the cartridge channel 4530.

In various embodiments, referring now to FIG. 152, a staple cartridge,such as staple cartridge 4600, for example, can comprise a compressible,implantable cartridge body 4610 and a plurality of staples 4620positioned therein. The cartridge body 4610 can comprise an outer layer4611 and an inner layer 4612. In certain embodiments, the inner layer4612 can comprise a plurality of pockets, such as pockets, or cavities,4615, for example, defined therein which can facilitate the collapse ofthe cartridge body 4610. In at least one such embodiment, the innerlayer 4612 can comprise a corrugated, or honeycomb-configured, latticewhich can be configured to withstand a compressive force, or pressure,as long as the compressive force, or pressure, does not exceed a certainthreshold value. When the threshold value has not been exceeded, theinner layer 4612 can deform at a linear, or at least substantiallylinear, rate with respect to the compressive force, or pressure, beingapplied. After the compressive force, or pressure, has exceeded thethreshold value, the inner layer 4612 can suddenly succumb to largedeflections and collapse, or buckle, as a result of the compressiveload. In various embodiments, the lattice of the inner layer 4612 can becomprised of a plurality of sub-layers 4612 a which can be connectedtogether. In at least one embodiment, each sub-layer 4612 a can comprisea plurality of alternating furrows and ridges, or waves, which can bealigned with the alternating furrows and ridges of an adjacent sub-layer4612 a. In at least one such embodiment, the furrows of a firstsub-layer 4612 a can be positioned adjacent to the ridges of a secondsub-layer 4612 a and, similarly, the ridges of the first sub-layer 4612a can be positioned adjacent to the furrows of the second sub-layer 4612a. In various embodiments, the adjacent sub-layers 4612 a can be adheredto one another and/or the outer layer 4611 by at least one adhesive,such as fibrin and/or protein hydrogel, for example. FIG. 153illustrates the staple cartridge 4600 after the cartridge body 4610 hasbeen collapsed and the staples 4620 have been deformed in order tocapture and hold tissue T against the cartridge body 4610.

In various embodiments, referring now to FIGS. 154-156, a staplecartridge, such as staple cartridge 4700, for example, can comprise acompressible, implantable cartridge body 4710 and a plurality of staples4720 positioned within the cartridge body 4710. Similar to the above,the cartridge body 4710 can comprise an outer layer 4711 and an innerlayer 4712, wherein the inner layer 4712 can comprise a plurality ofsub-layers 4712 a. Also similar to the above, each sub-layer 4712 a cancomprise alternating furrows 4717 and ridges 4718 which can be alignedwith one another to define pockets, or cavities, 4715 therebetween. Inat least one such embodiment, the furrows 4717 and/or the ridges 4718can extend along axes which are parallel to one another and/or parallelto a longitudinal axis 4709. In various embodiments, the staples 4720can be aligned in a plurality of staple rows which can extend along axeswhich are parallel to one another and/or parallel to the longitudinalaxis 4709. In various alternative embodiments, referring again to FIGS.152 and 153, the staples 4620 contained in the cartridge body 4600 canextend along axes which are traverse or perpendicular with respect tothe axes defined by the furrows and ridges of the sub-layers 4612 a.Referring again to FIGS. 154-156, the staples 4720 can extend throughthe furrows 4717 and the ridges 4718 wherein friction forces between thestaples 4720 and the sub-layers 4712 a can hold the staples 4720 withinthe cartridge body 4710. In certain embodiments, the plurality ofsub-layers 4712 a can be comprised of a buttress material and/or plasticmaterial, such as polydioxanone (PDS) and/or polyglycolic acid (PGA),for example, which can be configured to hold the staples 4720 in anupright orientation, for example, and/or hold the staples 4720 inalignment with respect to each other as illustrated in FIGS. 154 and155. FIG. 156 illustrates the staple cartridge 4700 after the cartridgebody 4710 has been collapsed and the staples 4720 have been deformed inorder to capture and hold tissue T against the cartridge body 4710.

In various embodiments, referring again to FIGS. 154-156, the cartridgebody 4710 can resiliently or elastically collapse when it is compressed.In at least one such embodiment, the waves formed within each sub-layer4712 a by the furrows 4717 and the ridges 4718 can be flattened, or atleast substantially flattened, when the cartridge body 4710 iscompressed which can collapse, or at least substantially collapse, thecavities 4715 defined therebetween. In various circumstances, thecartridge body 4710, or at least portions of the cartridge body 4710,can resiliently or elastically re-expand after the compressive force, orpressure, has been removed from the cartridge body 4710. In at least onesuch embodiment, the connections between the furrows 4717 and the ridges4718 of adjacent sub-layers 4712 a can remain intact, or at leastsubstantially intact, when the cartridge body 4710 is compressed suchthat, after the compression force has been removed from the cartridgebody 4710, the sub-layers 4712 a can bias themselves away from eachother and, as a result, at least partially re-expand the cartridge body4710. In certain embodiments, the cartridge body 4710 can be plasticallydeformed, or crushed, when it is compressed and, as a result, thecartridge body 4710 may not re-expand after the compressive force, orpressure, has been removed from the cartridge body 4710. In certainembodiments, referring now to FIG. 157, a staple cartridge, such asstaple cartridge 4800, for example, can comprise a crushable cartridgebody 4810 comprising an outer layer 4811 and an inner layer 4812,wherein the inner layer 4812 can comprise a corrugated,honeycomb-configured, lattice having a plurality of pockets, orcavities, 4815 defined therein. In various embodiments, the wallsdefining the lattice of inner layer 4812 can comprise one or moreweakened, or thin, cross-sections 4819 which can be configured to allowthe walls defining the lattice to break when the cartridge body 4810 iscompressed. In such circumstances, the cartridge body 4810 can becrushed when the staple cartridge 4800 is implanted.

In various embodiments, referring now to FIGS. 158-160, a staplecartridge, such as staple cartridge 4900, for example, can comprise acartridge body 4910 comprising an outer layer 4911 and a plurality ofcollapsible elements 4912 positioned intermediate top and bottomportions of the outer layer 4911, for example. Referring primarily toFIGS. 158 and 159, the staple cartridge 4900 can further comprise aplurality of staples 4920, wherein each staple 4920 can be positioned ina collapsible element 4912. More particularly, each collapsible element4912 can comprise a first portion 4912 a, a second portion 4012 b, and athird portion 4012 c which can co-operate to define a cavity 4915therein which is configured to receive a staple 4920. In use, further tothe above, the staple cartridge 4900 can be positioned within a staplecartridge channel and a compressive force can be applied to the tissuecontacting surface 4919 in order to compress the cartridge body 4910. Asthe tissue contacting surface 4919 is moved downwardly, the collapsibleelements 4912 can collapse. In such circumstances, the second portion4912 b of each collapsible element 4912 can collapse into acorresponding first portion 4912 a and, similarly, the third portion4912 c of each collapsible element 4912 can collapse into acorresponding second portion 4912 b. As the cartridge body 4910 iscompressed and the collapsible elements 4912 are collapsed, the staples4920 positioned within the collapsible elements 4912 can be deformed, asillustrated in FIG. 160. In various embodiments, the second portion 4912b of each collapsible element 4912 can be frictionally engaged and/orpress-fit within a corresponding first portion 4912 a such that, oncethe compressive force applied to the collapsible element 4912 exceedsthe retention force retaining the first portion 4912 a and the secondportion 4912 b in their extended position (FIG. 159), the first portion4912 a and the second portion 4912 b can begin to slide relative to oneanother. Similarly, the third portion 4912 c of each collapsible element4912 can be frictionally engaged and/or press-fit within a correspondingsecond portion 4912 b such that, once the compressive force applied tothe collapsible element 4912 exceeds the retention force retaining thesecond portion 4912 b and the third portion 4912 c in their extendedposition (FIG. 159), the second portion 4912 b and the third portion4912 c can begin to slide relative to one another.

In many embodiments described herein, a staple cartridge can comprise aplurality of staples therein. In various embodiments, such staples canbe comprised of a metal wire deformed into a substantially U-shapedconfiguration having two staple legs. Other embodiments are envisionedin which staples can comprise different configurations such as two ormore wires that have been joined together having three or more staplelegs. In various embodiments, the wire, or wires, used to form thestaples can comprise a round, or at least substantially round,cross-section. In at least one embodiment, the staple wires can compriseany other suitable cross-section, such as square and/or rectangularcross-sections, for example. In certain embodiments, the staples can becomprised of plastic wires. In at least one embodiment, the staples canbe comprised of plastic-coated metal wires. In various embodiments, acartridge can comprise any suitable type of fastener in addition to orin lieu of staples. In at least one such embodiment, such a fastener cancomprise pivotable arms which are folded when engaged by an anvil. Incertain embodiments, two-part fasteners could be utilized. In at leastone such embodiment, a staple cartridge can comprise a plurality offirst fastener portions and an anvil can comprise a plurality of secondfastener portions which are connected to the first fastener portionswhen the anvil is compressed against the staple cartridge. In certainembodiments, as described above, a sled or driver can be advanced withina staple cartridge in order to complete the forming process of thestaples. In certain embodiments, a sled or driver can be advanced withinan anvil in order to move one or more forming members downwardly intoengagement with the opposing staple cartridge and the staples, orfasteners, positioned therein.

In various embodiments described herein, a staple cartridge can comprisefour rows of staples stored therein. In at least one embodiment, thefour staple rows can be arranged in two inner staple rows and two outerstaple rows. In at least one such embodiment, an inner staple row and anouter staple row can be positioned on a first side of a cutting member,or knife, slot within the staple cartridge and, similarly, an innerstaple row and an outer staple row can be positioned on a second side ofthe cutting member, or knife, slot. In certain embodiments, a staplecartridge may not comprise a cutting member slot; however, such a staplecartridge may comprise a designated portion configured to be incised bya cutting member in lieu of a staple cartridge slot. In variousembodiments, the inner staple rows can be arranged within the staplecartridge such that they are equally, or at least substantially equally,spaced from the cutting member slot. Similarly, the outer staple rowscan be arranged within the staple cartridge such that they are equally,or at least substantially equally, spaced from the cutting member slot.In various embodiments, a staple cartridge can comprise more than orless than four rows of staples stored within a staple cartridge. In atleast one embodiment, a staple cartridge can comprise six rows ofstaples. In at least one such embodiment, the staple cartridge cancomprise three rows of staples on a first side of a cutting member slotand three rows of staples on a second side of the cutting member slot.In certain embodiments, a staple cartridge may comprise an odd number ofstaple rows. For example, a staple cartridge may comprise two rows ofstaples on a first side of a cutting member slot and three rows ofstaples on a second side of the cutting member slot. In variousembodiments, the staple rows can comprise staples having the same, or atleast substantially the same, unformed staple height. In certain otherembodiments, one or more of the staple rows can comprise staples havinga different unformed staple height than the other staples. In at leastone such embodiment, the staples on a first side of a cutting memberslot may have a first unformed height and the staples on a second sideof a cutting member slot may have a second unformed height which isdifferent than the first height, for example.

In various embodiments, referring now to FIGS. 161A-161D, an endeffector of a surgical stapler can comprise a cartridge attachmentportion, such as staple cartridge channel 5030, for example, a fastenercartridge removably positioned in the staple cartridge channel 5030,such as staple cartridge 5000, for example, and a jaw 5040 positionedopposite the staple cartridge 5000 and the staple cartridge channel5030. The staple cartridge 5000 can comprise a compressible body 5010and a plurality of staples 5020, and/or any other suitable fasteners, atleast partially positioned in the compressible body 5010. In at leastone such embodiment, each staple 5020 can comprise a base 5022 and, inaddition, legs 5021 extending upwardly from the base 5022, wherein atleast a portion of the legs 5021 can be embedded in the cartridge body5010. In various embodiments, the compressible body 5010 can comprise atop, or tissue-contacting, surface 5019 and a bottom surface 5018,wherein the bottom surface 5018 can be positioned against and supportedby a support surface 5031 of the staple cartridge channel 5030. Similarto the above, the support surface 5031 can comprise a plurality ofsupport slots 5032 (FIG. 161D), for example, defined therein which canbe configured to receive and support the bases 5022 of the staples 5020.In various embodiments, the end effector of the surgical stapler canfurther comprise a retention matrix, such as retention matrix 5050, forexample, which can be configured to engage the staples 5020 and capturetissue therebetween. In at least one such embodiment, the retentionmatrix 5050 can be removably mounted to the jaw 5040. In use, once thestaple cartridge 5000 has been positioned within the staple cartridgechannel 5030, the jaw 5040, and the retention matrix 5050 attachedthereto, can be moved toward the staple cartridge 5000 and the staplecartridge channel 5030. In at least one embodiment, the jaw 5040 can bemoved downwardly along an axis 5099 such that the jaw 5040 and thestaple cartridge channel 5030 remain parallel, or at least substantiallyparallel, to one another as the jaw 5040 is closed. More particularly,in at least one such embodiment, the jaw 5040 can be closed in a mannersuch that a tissue-contacting surface 5051 of the retention matrix 5050is parallel, or at least substantially parallel, to thetissue-contacting surface 5019 of the staple cartridge 5000 as the jaw5040 is moved toward the staple cartridge 5000.

In various embodiments, referring now to FIG. 161A, the retention matrix5050 can be detachably secured to the jaw 5040 such that there islittle, if any, relative movement between the retention matrix 5050 andthe jaw 5040 when the retention matrix 5050 is attached to the jaw 5040.In at least one embodiment, the jaw 5040 can comprise one or moreretention features which can be configured to hold the retention matrix5050 in position. In at least one such embodiment, the retention matrix5050 can be snap-fit and/or press-fit into the jaw 5040. In certainembodiments, the retention matrix 5050 can be adhered to the jaw 5040utilizing at least one adhesive. In any event, the jaw 5040 can be movedinto a position in which the retention matrix 5050 is in contact withthe tissue T and the tissue T is positioned against thetissue-contacting surface 5019 of the staple cartridge 5000. When thetissue T is positioned against the staple cartridge 5000 by the jaw5040, the compressible body 5010 of the staple cartridge 5000 may or maynot be compressed by the jaw 5040. In either circumstance, in variousembodiments, the legs 5021 of the staples 5200 may not protrude throughthe tissue-contacting surface 5019 of the staple cartridge 5000 asillustrated in FIG. 161A. Furthermore, as also illustrated in FIG. 161A,the jaw 5040 can hold the tissue T against the compressible body 5010without engaging the retention matrix 5050 with the staples 5020. Suchembodiments can permit a surgeon to open and close the jaw 5040 multipletimes in order to obtain a desired positioning of the end effectorwithin a surgical site, for example, without damaging the tissue T.Other embodiments are envisioned, however, where the staple tips 5023can protrude from the tissue-contacting surface 5019 prior to thecartridge body 5010 being compressed by the anvil 5040. Once the endeffector has been suitably positioned, referring now to FIG. 161B, thejaw 5040 can be moved downwardly toward the staple cartridge channel5030 such that the compressible body 5010 is compressed by the anvil5040 and such that the tissue-contacting surface 5019 is pusheddownwardly relative to the staples 5020. As the tissue-contactingsurface 5019 is pushed downwardly, the tips 5023 of the staple legs 5021can pierce the tissue-contacting surface 5019 and pierce at least aportion of the tissue T. In such circumstances, the retention matrix5050 may be positioned above the staples 5020 such that the retentionapertures 5052 of retention matrix 5050 are aligned, or at leastsubstantially aligned, with the tips 5023 of the staple legs 5021.

As the retention matrix 5050 is pushed downwardly along the axis 5099,referring now to FIG. 161C, the staple legs 5021 of staples 5020 canenter into the retention apertures 5052. In various embodiments, thestaple legs 5021 can engage the side walls of the retention apertures5052. In certain embodiments, as described in greater detail below, theretention matrix 5050 can comprise one or more retention membersextending into and/or around the retention apertures 5052 which canengage the staple legs 5021. In either event, the staple legs 5021 canbe retained in the retention apertures 5052. In various circumstances,the tips 5023 of the staple legs 5021 can enter into the retentionapertures 5052 and can frictionally engage the retention members and/orthe side walls of the apertures 5052. As the retention matrix 5050 ispushed toward the bases 5022 of the staples 5020, the staple legs 5021can slide relative to the side walls and/or the retention members. As aresult of the above, sliding friction forces can be created between thestaple legs 5021 and the retention matrix 5050 wherein such slidingfriction forces can resist the insertion of the retention matrix 5050onto the staples 5020. In various embodiments, the sliding frictionforces between the retention matrix 5050 and the staples 5020 can beconstant, or at least substantially constant, as the retention matrix5050 is slid downwardly along the staple legs 5021 of the staples 5020.In certain embodiments, the sliding friction forces may increase and/ordecrease as the retention matrix 5050 is slid downwardly along thestaple legs 5021 owing to variations in geometry of the staple legs5021, the retention apertures 5052, and/or the retention membersextending into and/or around the retention apertures 5052, for example.In various embodiments, the insertion of the retention matrix 5050 ontothe staples 5020 can also be resisted by the compressible body 5010 ofthe staple cartridge 5000. More particularly, the compressible body 5010can be comprised of an elastic material, for example, which can apply aresistive force to the retention matrix 5050 which increases as thedistance in which the compressible body 5010 is compressed increases. Inat least one such embodiment, the increase in the resistive forcegenerated by the cartridge body 5010 can be linearly proportional, or atleast substantially linearly proportional, with respect to the distancein which the cartridge body 5010 is compressed. In certain embodiments,the increase in the resistive force generated by the cartridge body 5010can be geometrically proportional with respect to the distance in whichthe cartridge body 5010 is compressed.

In various embodiments, further to the above, a sufficient firing forcecan be applied to the jaw 5040 and the retention matrix 5050 in order toovercome the resistive and friction forces described above. In use, theretention matrix 5050 can be seated to any suitable depth with respectto the staples 5020. In at least one embodiment, the retention matrix5050 can be seated to a depth with respect to the bases 5022 of thestaples 5020 in order to secure two or more layers of tissue togetherand generate compressive forces, or pressure, within the tissue. Invarious circumstances, the system comprising the retention matrix 5050and the staples 5020 can allow a surgeon to select the amount ofcompressive forces, or pressure, that is applied the tissue by selectingthe depth in which the retention matrix 5050 is seated. For example, theretention matrix 5050 can be pushed downwardly toward the staple bases5022 of the staples 5020 until the retention matrix 5050 is seated acertain depth 5011 away from the bottom of the support slots 5032,wherein a shorter depth 5011 can result in higher compressive forces, orpressure, being applied to the tissue T than a taller depth 5011 whichcan result in lower compressive forces, or pressure, being applied tothe tissue T. In various embodiments, the compressive forces, orpressures, applied to the tissue T can be linearly proportional, or atleast substantially linearly proportional, to the depth 5011 in whichthe retention matrix 5050 is seated. In various circumstances, thecompressive forces, or pressure, applied to the tissue T can depend onthe thickness of the tissue T positioned between the retention matrix5050 and the staple cartridge 5020. More particularly, for a givendistance 5011, the presence of thicker tissue T can result in highercompression forces, or pressure, than the presence of thinner tissue T.

In various circumstances, further to the above, a surgeon can adjust thedepth in which the retention matrix 5050 is seated in order to accountfor thicker and/or thinner tissue positioned within the end effector andto apply a certain or predetermined pressure to the tissue T regardlessof the tissue thickness. For example, the surgeon can seat the retentionmatrix 5050 to a shorter depth 5011 when fastening thinner tissue T or ataller depth 5011 when fastening thicker tissue T in order to arrive atthe same, or at least substantially the same, compression pressurewithin the tissue. In certain embodiments, further to the above, asurgeon can selectively determine the amount of compressive pressure toapply to the tissue T positioned between the retention matrix 5050 andthe staple cartridge 5010. In various circumstances, a surgeon canengage the retention matrix 5050 with the staples 5020 and position theretention matrix 5050 a first distance away from the bases 5022 of thestaples 5020 in order to apply a first compressive pressure to thetissue. The surgeon can alternatively position the retention matrix 5050a second distance away from the bases 5022, which is shorter than thefirst distance, in order to apply a second compressive pressure to thetissue which is greater than the first pressure. The surgeon canalternatively position the retention matrix 5050 a third distance awayfrom the bases 5022, which is shorter than the second distance, in orderto apply a third compressive pressure to the tissue which is greaterthan the second pressure. In various embodiments, the fastening systemcomprising the retention matrix 5050 and the staples 5020 can beconfigured to permit a surgeon to apply a wide range of compressivepressures to the targeted tissue.

In various embodiments, referring now to FIG. 161D, the staple legs 5021can be inserted through the retention matrix 5050 such that the stapleleg tips 5023 extend above the top surface of the retention matrix 5050.In at least one embodiment, referring again to FIG. 161C, the jaw 5040can further comprise clearance apertures 5042 defined therein which canbe configured to receive the staple leg tips 5023 as they pass throughthe retention apertures 5052 in the retention matrix 5050. In at leastone such embodiment, the clearance apertures 5042 can be aligned withthe retention apertures 5052 such that the legs 5021 do not contact thejaw 5040. In various embodiments, the clearance apertures 5042 can havea sufficient depth such that the staple legs 5021 do not contact the jaw5040 regardless of the distance in which the retention matrix 5050 isseated. After the retention matrix 5050 has been engaged with thestaples 5020 and seated to a desired position, referring now to FIG.161D, the staple cartridge channel 5030 and the jaw 5040 can be movedaway from the tissue T. More particularly, the staple cartridge channel5030 can be detached from the implanted staple cartridge 5000 and theanvil 5040 can be detached from the implanted retention matrix 5050. Asthe jaw 5040 is moved away from the retention matrix 5050 and the staplesupports 5032 are moved away from the staple bases 5022, the distance5011 between the retention matrix 5050 and the bottom of the bases 5022can be maintained eventhough the jaw 5040 and the staple cartridgechannel 5030 are no longer providing support thereto. In variousembodiments, the static friction forces between the staple legs 5021 andthe retention matrix 5050 can be sufficient to maintain the retentionmatrix 5050 in position despite a biasing force being applied to theretention matrix 5050 by the compressed cartridge body 5010 and/or thecompressed tissue T. In at least one such embodiment, the cartridge body5010 can be comprised of a resilient material which, when compressed,can apply an elastic biasing force to the retention matrix 5050 and thestaples 5020 in a manner which tends to push the retention matrix 5050and the staples 5020 apart, although such movement is opposed by thefrictional engagement between the staple legs 5021 and the retentionmatrix 5050.

In various embodiments, as described above, a retention matrix cancomprise a plurality of retention apertures, wherein each retentionaperture can be configured to receive a leg of a fastener therein. In atleast one embodiment, referring now to FIG. 162, a portion of aretention matrix 5150 is illustrated therein which can comprise aretention aperture 5152 defined by a perimeter 5156. In variousembodiments, the perimeter 5156 of the aperture 5152 can comprise acircular, or at least substantially circular, profile and/or any othersuitable profile. In certain embodiments, the retention matrix 5150 cancomprise one or more retention members, such as retention members 5153,for example, which extend into the aperture 5152 and can be configuredto engage a fastener leg when the fastener leg is inserted therethrough.In at least one such embodiment, each retention member 5153 can comprisea cantilever which extends inwardly toward a center axis 5159, i.e.,toward the center of the aperture 5152. In various embodiments, eachcantilever can comprise a first end which is attached to the retentionmatrix body 5158 and a second end which forms the perimeter 5156 of theretention aperture 5152. In certain embodiments, the perimeter 5156 of aretention aperture 5152 can be defined by a first diameter, or width,and a fastener leg can be defined by a second diameter, or width,wherein the second diameter can be larger than the first diameter. In atleast one such embodiment, the fastener leg can be configured to contactand deflect one or more of the retention members 5153 in order toincrease the diameter of the retention aperture 5152 as the fastener legis being inserted therethrough. In certain embodiments, further to theabove, the fastener leg can define a perimeter which is larger than theperimeter 5156 of the retention aperture 5152 such that the fastener legcan expand the perimeter 5156 when the fastener leg is inserted therein.

In various embodiments, referring again to FIG. 162, the aperture 5152can be defined by the deformable members 5153, wherein each deformablemember 5153 can be configured to deflect relative to, or independentlyof, the other deformable members 5153. In at least one such embodiment,adjacent deformable members 5153 can be separated by slots 5154 whichcan be configured to permit each deformable member 5153 to flex relativeto the others. In certain embodiments, each slot 5154 can comprise afirst end 5155 in the retention matrix body 5158, a second end openinginto the retention aperture 5152, and a constant, or at leastsubstantially constant, width extending between the first end 5155 andthe second end. In various other embodiments, the width of each slot5154 may not be constant and each slot 5154 may increase and/or decreasein width between the first and second ends thereof. In certainembodiments, the first ends 5155 of the slots 5154 can comprise anenlarged portion, such as a circular portion, which can provide, one,strain relief to the bases of the deformable members 5153 attached tothe retention matrix body 5158 and, two, means for increasing theflexibility of the deformable members 5153. In various embodiments, thegeometry of the deformable members 5153, and/or slots 5154, can beselected so as to provide the deformable members 5153 with a desiredflexibility. In certain embodiments, for example, the slots 5154 can belengthened in order to create longer deformable members 5153 which canbe more flexible than deformable members 5153 having a shorter length.In at least one embodiment, the width of each deformable member 5153 canbe selected so as to provide a desired flexibility thereof. Moreparticularly, deformable members having a thinner width can be moreflexible than deformable members having a thicker width. In certainembodiments, referring again to FIG. 162, the first ends of thecantilevers of deformable members 5153 attached to the retention matrixbody 5158 can be wider than the second ends of the cantilevers. In atleast one such embodiment, the cantilevers can be tapered in a linear,or at least substantially linear, manner between the first and secondends thereof.

In various embodiments, referring again to FIG. 162, the retentionmatrix body 5158 can comprise a flat, or at least substantially flat,sheet of material having a tissue-contacting surface 5151 and a topsurface 5157. In at least one such embodiment, the tissue-contactingsurface 5151 and the top surface 5157 can be parallel, or at leastsubstantially parallel, to one another. In various embodiments, eachdeformable member 5153 can comprise a first portion 5153 a and a secondportion 5153 b, wherein the first portion 5153 a can extend in a firstdirection and the second portion 5153 b can extend in a different, orsecond, direction. In at least one such embodiment, the retention matrixbody 5158 can define a plane and the first portions 5153 a of thedeformable members 5153 can lie within such a plane. In variousembodiments, the second portions 5153 b of the deformable members 5153can extend at an angle relative to the first portions 5153 a. In atleast one such embodiment, the second portions 5153 b can extend indirections which are pointed away from the top surface 5157 of theretention matrix body 5158 and, in certain embodiments, the secondportions 5153 b can converge toward the central axis 5159 of theretention aperture 5152. In any event, in various embodiments, thesecond portions 5153 b can be configured to deflect away from thecentral axis 5159 when the fastener leg is inserted therethrough. Inembodiments where a staple leg 5021 of a staple 5020 is inserted into aretention aperture 5152, the deformable members 5153 can deform in adirection which is generally away from the bases 5122 of the staples5120. In certain embodiments, as a result, the deformable members 5153can deflect in a general direction which is the same as, or at leastsubstantially the same as, the direction in which the staple legs 5021are being inserted.

In various embodiments, referring again to FIG. BD, the second portions5153 b of the deformable members 5153 can each comprise a sharp tip, forexample, which can be configured to slide against a staple leg 5021 asthe staple leg 5021 is inserted therein. The sharp tips of the secondportions 5153 b can also be configured to bite into the staple leg 5021in the event that the staple leg 5021 were to be pulled in the oppositedirection, i.e., in a direction which would remove the staple leg 5021from the retention aperture 5052. In certain circumstances, the secondportions 5153 b can be inclined at an angle relative to the side of thestaple leg 5021 which is greater than 90 degrees and, as a result, thesecond portions 5153 b may dig, or burrow, into the side of the stapleleg 5021 when the staple leg 5021 experiences a force which tends towithdraw the staple leg 5021 from the retention aperture 5052. Incertain embodiments, the staple legs 5021 can comprise indentationsand/or concavities, such as microindentations, for example, in thesurfaces thereof which can be configured to receive the tips of thedeformable members 5053, for example, therein. In at least one suchembodiment, the tips of the deformable members 5053 can catch in andburrow into the indentations in the staple legs 5021 when a withdrawingforce is applied to the staple legs 5021. In various embodiments, as aresult of the burrowing of the second portions 5153 b into the staplelegs 5021, forces acting to remove the staple legs 5021 from theretention apertures 5022 may only seat the second portions 5153 b deeperinto the staple legs 5021 and increase the force required to remove thestaple legs 5021. Furthermore, owing to the upward inclination of thesecond portions 5153 b, in at least one embodiment, the second portions5153 b can be more permissive to the insertion of a staple leg 5021within a retention aperture 5152 and more resistive to withdrawal of thestaple leg 5021. In at least one embodiment, as a result, the forcerequired to insert a staple leg 5021 into a retention aperture 5022 maybe less than the force required to remove the staple leg 5021 from theretention aperture 5022. In various embodiments, the force needed toremove the staple leg 5021 from the retention aperture 5022 can beapproximately 50 percent greater than the force needed to insert thestaple leg 5021 into the retention aperture 5022, for example. Invarious other embodiments, the force needed to remove the staple leg5021 may between approximately 10 percent and approximately 100 percentgreater than the force needed to insert the staple leg 5021, forexample. In certain embodiments, the force needed to remove the stapleleg 5021 may be approximately 100 percent, approximately 150 percent,approximately 200 percent, and/or greater than approximately 200 percentlarger than the force needed to insert the staple leg 5021, for example.

In certain embodiments, referring again to FIG. 162, the second portions5153 b can be arranged circumferentially around the aperture 5152 andcan define a pocket therebetween. More particularly, the second portions5153 b can define a pocket 5160 which can be configured to receive thetip of the fastener leg when it is inserted into the retention aperture5152. In various embodiments, the second portions 5153 b of thedeformable members 5153 can comprise an annular, or an at leastsubstantially annular, contour which can co-operatively define anannular, or at least substantially annular, profile of the pocket 1560,for example. In at least one such embodiment, the second portions 5153 bcan define a conical or frustoconical pocket. In various embodiments,the pocket can be defined by a suitable number of deformable members,such as four deformable members 5153 (FIG. 162), six deformable members5153 (FIG. 163), or eight deformable members 5153 (FIG. 164), forexample. In certain embodiments, referring now to FIG. 165, thedeformable members of a retention matrix, such as retention matrix 5250,for example, can form a pyramidal shape, or an at least substantiallypyramidal shape, for example. In various embodiments, a retention matrix5250 can comprise a plurality of retention apertures, such as retentionaperture 5252, for example, which can be defined by a perimeter 5256. Invarious embodiments, the perimeter 5256 can comprise a polygonal, or atleast substantially polygonal, profile and/or any other suitableprofile. In certain embodiments, the retention matrix 5250 can compriseone or more retention members, such as retention members 5253, forexample, which extend into the aperture 5252 and can be configured toengage a fastener leg when the fastener leg is inserted therethrough. Inat least one such embodiment, each retention member 5253 can comprise acantilever which extends inwardly toward a center axis 5259, i.e.,toward the center of the aperture 5252. In various embodiments, eachcantilever can comprise a first end which is attached to the retentionmatrix body 5258 and a second end which forms the perimeter 5256 of theretention aperture 5252. In certain embodiments, the perimeter 5256 of aretention aperture 5252 can be defined by a first diameter, or width,and a fastener leg can be defined by a second diameter, or width,wherein the second diameter can be larger than the first diameter. In atleast one such embodiment, the fastener leg can be configured to contactand deflect one or more of the retention members 5253 in order toincrease the diameter of the retention aperture 5252 as the fastener legis being inserted therethrough. In certain embodiments, further to theabove, the fastener leg can define a perimeter which is larger than theperimeter 5256 of the retention aperture 5252 such that the fastener legcan expand the perimeter 5256 when the fastener leg is inserted therein.

In various embodiments, referring again to FIG. 165, the aperture 5252can be defined by the deformable members 5253, wherein each deformablemember 5253 can be configured to deflect relative to, or independentlyof, the other deformable members 5253. In at least one such embodiment,adjacent deformable members 5253 can be separated by slots 5254 whichcan be configured to permit each deformable member 5253 to flex relativeto the others. In various embodiments, the retention matrix body 5258can comprise a flat, or at least substantially flat, sheet of materialhaving a tissue-contacting surface 5251 and a top surface 5257. In atleast one such embodiment, the tissue-contacting surface 5251 and thetop surface 5257 can be parallel, or at least substantially parallel, toone another. In various embodiments, each deformable member 5253 cancomprise a first portion 5253 a and a second portion 5253 b, wherein thefirst portion 5253 a can extend in a first direction and the secondportion 5253 b can extend in a different, or second, direction. In atleast one such embodiment, the retention matrix body 5258 can define aplane and the first portions 5253 a of the deformable members 5253 canlie within such a plane. In various embodiments, the second portions5253 b of the deformable members 5253 can extend at an angle relative tothe first portions 5253 a. In at least one such embodiment, the secondportions 5253 b can extend in directions which are pointed away from thetop surface 5257 of the retention matrix body 5258 and, in certainembodiments, the second portions 5253 b can converge toward the centralaxis 5259 of the retention aperture 5252. In any event, in variousembodiments, the second portions 5253 b can be configured to deflectaway from the central axis 5259 when the fastener leg is insertedtherethrough. In certain embodiments, referring again to FIG. 165, thesecond portions 5253 b can be arranged circumferentially around theaperture 5252 and can define a pocket therebetween. More particularly,the second portions 5253 b can define a pocket which can be configuredto receive the tip of the fastener leg when it is inserted into theretention aperture 5252. In various embodiments, the second portions5253 b of the deformable members 5253 can define a polygonal, or an atleast substantially polygonal, pocket, for example. In variousembodiments, the pocket can be defined by a suitable number ofdeformable members, such as four deformable members 5253 (FIG. 165)which can define a square, six deformable members 5253 (FIG. 166) whichcan define a hexagon, or eight deformable members 5253 (FIG. 167) whichcan define an octagon, for example.

In various embodiments, referring now to FIG. 168, a retention matrix,such as retention matrix 5350, for example, can be formed from a flat,or an at least substantially flat, sheet of material such as titaniumand/or stainless steel, for example. In at least one such embodiment, aplurality of apertures 5352 can be formed in the body 5358 of theretention matrix 5350 by one or more stamping processes. The sheet ofmaterial can be positioned in a stamping die which, when actuated, canpunch out certain portions of the material in order to form slots 5354,apertures 5355 of slots 5354, and/or the perimeter 5356 of the retentionaperture 5352, for example. The stamping die can also be configured tobend the deformable members 5353 in a suitable configuration. In atleast one such embodiment, the stamping die can deform the secondportions 5353 b upwardly relative to the first portions 5353 a along acrease line 5353 c. In various embodiments, referring now to FIG. 169, aretention matrix, such as retention matrix 5450, for example, cancomprise a plurality of retention apertures 5452. Similar to the above,the perimeter 5456 of each retention aperture 5452 can be defined by aplurality of deformable members 5453 separated by slots, or slits, 5454.In at least one such embodiment, the entirety of each deformable member5453 can be bent upwardly wherein the free ends of the cantileverscomprising the deformable members 5453 can define the perimeter 5456. Invarious embodiments, the retention matrix 5450 can comprise a pluralityof apertures 5455 surrounding, or at least substantially surrounding,the retention aperture 5452. In at least one such embodiment, theapertures 5455 can be arranged in a circular array surrounding orenclosing a perimeter defined by the fixed ends of the cantilevers ofthe deformable members 5453. In certain embodiments, each aperture 5455can comprise a circular, or at least substantially circular, perimeterand/or any other suitable perimeter. In use, the apertures 5455 canprovide, one, strain relief to the bases of the deformable members 5453attached to the retention matrix body 5458 and, two, means forincreasing the flexibility of the deformable members 5453. In variousembodiments, larger apertures 5455 can provide more flexibility to thedeformable members 5453 as compared to smaller apertures 5455.Furthermore, apertures 5455 which are closer to the deformable members5453 can provide more flexibility as compared to apertures 5455 whichare further away.

In various embodiments, referring now to FIG. 170, a retention matrix,such as retention matrix 5550, for example, can comprise a plurality ofretention apertures 5552. Each retention aperture 5552 can comprise anelongate slot 5554 having enlarged circular, or at least substantiallycircular, ends 5555. In at least one such embodiment, the ends 5555 canbe defined by a diameter which is wider than the slot 5554. In certainembodiments, the elongate slot 5554 and the ends 5555 can positionedalong, and/or centered along, a longitudinal axis 5559. In variousembodiments, the slot 5554 and the ends 5555 can define two opposingtabs 5553 which can be configured to engage a leg of a fastener anddeflect as the fastener leg is inserted therethrough. In at least oneembodiment, ends 5555 having a larger perimeter, or diameter, can definelonger tabs 5553 which can be more flexible than tabs 5553 defined byends 5555 having a smaller perimeter, or diameter. In variousembodiments, the ends 5555 can have the same perimeter and diameter and,in at least one such embodiment, each tab 5553 can be symmetrical aboutan axis which is perpendicular, or at least substantially perpendicular,to the longitudinal axis 5559. Alternatively, the ends 5555 can havedifferent perimeters and/or diameters wherein, in at least oneembodiment, each tab 5553 may not be symmetrical about its axis. In atleast one such alternative embodiment, the tabs 5553 may twist abouttheir axes as the fastener leg is inserted through the retentionaperture 5552. In various embodiments, referring now to FIG. 171, aretention matrix, such as retention matrix 5650, for example, cancomprise a plurality of retention apertures 5652. Each retentionaperture 5652 can comprise an elongate slot 5654 comprising circular, orat least substantially circular, ends 5655. In at least one suchembodiment, the elongate slot 5654 and the ends 5655 can be positionedalong, and/or centered along, a longitudinal axis 5659. In variousembodiments, each end 5655 can be defined by a diameter which is thesame as, or at least substantially the same as, the width of the slot5654.

In various embodiments, referring now to FIG. 172, a retention matrix,such as retention matrix 5750, for example, can comprise a plurality ofretention apertures 5752. Each retention aperture 5752 can comprise aplurality of slots, such as slots 5754, for example, having enlargedends 5755. In at least one such embodiment, the slots 5754 and the ends5755 can be positioned along and/or centered along longitudinal axes5759. In various embodiments, the axes 5759 can extend in directionswhich are perpendicular or transverse to one another. In certainembodiments, the slots 5754 and the ends 5755 can define four tabs 5753,for example, which can be configured to engage a fastener leg anddeflect when the fastener leg is inserted through the retention aperture5752. In at least one embodiment, each tab 5753 can comprise atriangular, or at least substantially triangular, configuration, such asan equilateral triangle, for example. In various other embodiments,referring now to FIG. 173, a retention matrix, such as retention matrix5850, for example, can comprise a plurality of retention apertures 5852.Each retention aperture 5852 can comprise a plurality of slots, such asslots 5854, for example, having ends 5855, wherein the slots 5854 andthe ends 5855 can be positioned along and/or centered along longitudinalaxes 5859. In various embodiments, the axes 5859 can extend indirections which are perpendicular or transverse to one another. Incertain embodiments, the slots 5854 and the ends 5855 can define tabs5853 which can be configured to engage a fastener leg and deflect whenthe fastener leg is inserted through the retention aperture 5852. In atleast one embodiment, each tab 5853 can comprise an arcuate profile.More particularly, each tab 5853 can comprise a curved end, as opposedto a pointed end depicted in FIG. 170, which can be configured tocontact the fastener leg.

In various embodiments, referring now to FIG. 174, a retention matrix,such as retention matrix 5950, for example, can comprise a plurality ofretention apertures 5952. Each retention aperture 5952 can comprise aplurality of slots, such as slots 5954, for example, wherein each slot5954 can extend along, and/or can be centered along, an axis 5959. Invarious embodiments, the axes 5959 can be transverse to each other and,in at least one such embodiment, the axes 5959 can be arranged such thatall of the axes 5959 extend through a center of the retention aperture5952 and are spaced equidistantly, or at least substantiallyequidistantly, from each other. In at least one embodiment, each slot5954 can comprise an open end facing the center of the retentionaperture 5952 and a second, or closed, end 5955 at the opposite end ofthe slot 5954. Similar to the above, the slots 5954 and the ends 5955can define three tabs 5953, for example, which can be configured toengage a fastener leg and deflect when the fastener leg is inserted intothe retention aperture 5952. In various embodiments, each tab 5953 cancomprise an arcuate configuration extending between adjacent ends 5955of the slots 5954. In various embodiments, referring now to FIG. 175, aretention matrix, such as retention matrix 6050, for example, cancomprise a plurality of retention apertures 6052. Each retentionaperture 6052 can comprise a tab 6053 which can be configured to engagea fastener leg and to deflect when the fastener leg is inserted into theretention aperture 6052. In at least one such embodiment, the tab 6053can comprise a base fixed to the retention matrix body 6058 and a freeend comprising an arcuate or curved profile 6056 which can be configuredto contact the fastener leg. In certain embodiments, the fastener legcan be a staple leg comprised of a round wire wherein the curved profile6056 can be configured to match, or at least substantially match, acurved outer surface of the round wire.

In various embodiments, referring again to FIG. 175, the retentionmatrix body 6058 can comprise a plurality of slots 6054 and apertures6055 which can be configured to define the tab 6053 and various portionsof the retention aperture 6052. In at least one embodiment, the tab 6053can comprise a rectangular configuration comprising parallel, or atleast substantially parallel, sides. In certain embodiments, referringnow to FIG. 176, a retention matrix, such as retention matrix 6150, forexample, can comprise a plurality of retention apertures 6152. Eachretention aperture 6152 can comprise a tab 6153 which can be configuredto engage a fastener leg and to deflect when the fastener leg isinserted into the retention aperture 6152. In at least one suchembodiment, the tab 6153 can comprise a base fixed to the retentionmatrix body 6158 and a free end comprising an arcuate or curved profile6156 which can be configured to contact the fastener leg. In variousembodiments, the retention matrix body 6158 can comprise a plurality ofslots 6154 and apertures 6155 which can be configured to define the tab6153 and various portions of the retention aperture 6152. In at leastone embodiment, the tab 6153 can comprise a tapered configurationcomprising arcuate sides. In at least one such embodiment, the tab 6153can taper geometrically with the base being wider than the free end, forexample.

In various embodiments, as described above, a fastening system cancomprise a plurality of staples comprising staple legs which areinserted through a plurality of retention apertures in a retentionmatrix. In certain embodiments, as described in greater detail below,the staples can be held in a first jaw and the retention matrix can beheld in a second jaw, wherein at least one of the first jaw and thesecond jaw can be moved toward the other. In various circumstances, thestaples positioned within the first jaw can be secured therein such thatthe staple legs are aligned with the retention apertures when theretention matrix is engaged with the staple legs. In certainembodiments, referring to FIGS. 177 and 178, a fastener system cancomprise a staple cartridge 6200, for example, positioned in a first jawof a surgical stapler and a retention matrix 6250, for example,positioned in a second jaw of the surgical stapler. Referring now toFIGS. 184 and 185, further to the above, the retention matrix 6250 cancomprise a plurality of retention apertures 6252, wherein each retentionaperture 6252 can comprise a perimeter 6256 defined by one or moredeflectable members 6253. In at least one such embodiment, further tothe above, the deflectable members 6253 defining each aperture 6252 candefine a pocket 6201. In various embodiments, each pocket 6201 cancomprise a curved and/or concave surface, for example, which can beconfigured to guide a tip of a staple leg into the aperture 6252 in theevent that the staple leg is misaligned with the retention aperture 6252and initially contacts the deflectable members 6253 and/or thetissue-contacting surface 6251, for example.

In various embodiments, further to the above, the fastening system canfurther comprise a plurality of staples 6220 comprising staple legs 6221which can be inserted through the retention apertures 6252 in theretention matrix 6250. In at least one such embodiment, each staple 6220can comprise a substantially U-shaped configuration, for example,comprising a base 6222 from which the staple legs 6221 can extendupwardly. In various embodiments, referring now to FIGS. 180 and 181,the retention apertures 6252 in the retention matrix 6250 can bearranged in two parallel, or at least substantially parallel,longitudinal rows, for example, which can extend along, or parallel to,a longitudinal axis of the retention matrix. In certain embodiments, theretention apertures 6252 in a first row can be offset, or staggered,with respect to the retention apertures 6252 in a second row. In atleast one such embodiment, each staple 6220 can comprise a first stapleleg 6221 positioned in a retention aperture 6252 in the first row of anda second staple leg 6221 positioned in a retention aperture 6252 in thesecond row wherein, as a result, the bases 6222 can extend in adirection which is transverse to the longitudinal axis of the retentionmatrix 6250. In at least one such embodiment, the staples 6220 can beparallel, or at least substantially parallel, to one another. Moreparticularly, a base 6222 a of a staple 6220 a be parallel to, or atleast substantially parallel to, a base 6222 b of a staple 6220 b whichcan be parallel to, or at least substantially parallel to, a base 6222 cof a staple 6220 c, for example. In at least one embodiment, the staplelegs 6221 a of staple 6220 a can define a plane which is parallel to, orat least substantially parallel to, a plane defined by the staple legs6221 b of staple 6220 b which can be parallel to, or at leastsubstantially parallel to, a plane defined by the staple legs 6221 ofstaple 6220 c, for example.

In various embodiments, referring now to FIGS. 177 and 179, the staplecartridge 6200 can comprise a plurality of staples 6220 and, inaddition, an alignment matrix 6260 comprising a plurality of alignmentguides, such as slots, grooves, and/or apertures, for example, which canbe configured to align the staples 6220. In various circumstances, thealignment matrix 6260 can be configured such that the staple legs 6221of the staples 6220 are aligned with the retention apertures 6252 in theretention matrix 6250 before the retention matrix 6250 is engaged withthe staple legs 6221. In various embodiments, referring now to FIGS. 182and 183, the alignment matrix 6260 can comprise a plurality of alignmentapertures 6262 which can be configured to closely receive the staplelegs 6221 of the staples 6220. In at least one such embodiment, eachstaple 6220 can comprise a base 6222 and two staple legs 6221 extendingfrom the base 6222 wherein the bases 6222 of the staples 6220 can extendaround a bottom surface 6264 of the retention matrix 6260 and the staplelegs 6221 can extend upwardly through the alignment apertures 6262. Incertain embodiments, each alignment aperture 6262 can be circular, or atleast substantially circular, and can be defined by a diameter which isequal to or slightly larger than the diameter of the staple leg 6221extending therethrough. In various embodiments, the alignment matrix6260 can further comprise a plurality of raised members 6263 which canextend upwardly from the top surface 6261 of the alignment matrix 6260and surround, or at least partially surround, the alignment apertures6262. In certain embodiments, the raised members 6263 can provide forlonger alignment apertures 6262 wherein, in various circumstances,longer apertures 6262 can provide more control over the alignment of thestaple legs 6221 than shorter apertures 6262.

In use, in various embodiments, a first jaw supporting the staplecartridge 6200 can be positioned on one side of the tissue that is to bestapled and a second jaw supporting the retention matrix 6250 can bepositioned on the other side of the tissue. Once the jaws have beensuitably positioned relative to the tissue, in certain embodiments, thesecond jaw and the retention matrix 6250 can be moved toward the staplecartridge 6200. As the staple legs 6221 are being inserted through theretention apertures 6252 of the retention matrix 6250, in variousembodiments, a tissue-contacting, or bottom, surface 6251 of theretention matrix 6250 can contact the tissue and press the tissueagainst the tissue-contacting, or top, surface 6261 of the alignmentmatrix 6260. In various other embodiments, as described in greaterdetail further below, the staple cartridge 6200 can further comprise acompressible cartridge body positioned above the top surface 6261 of thealignment matrix 6260, for example, which can contact the tissue. Incertain embodiments, referring again to FIGS. 179 and 183, the alignmentmatrix 6260 can further comprise one or more apertures 6203 definedtherein which, when the alignment matrix 6260 is positioned againsttissue, can be configured to receive a portion of the tissue therein. Inembodiments where a compressible cartridge body is positioned aboveand/or against the alignment matrix 6260, a portion of the compressiblecartridge body can enter into the apertures 6203 when the cartridge bodyis compressed. Similarly, the retention matrix 6250 can comprise aplurality of apertures 6202 which can be configured to receive at leasta portion of the tissue therein when the retention matrix 6250 ispositioned against the tissue.

As the staple legs 6221 of the staples 6220 are inserted through theretention apertures 6252 of the retention matrix 6250, further to theabove, the tips of the staple legs 6221 may protrude upwardly from thetop surface 6257 of the retention matrix 6250. In various circumstances,as described above, the tips of the staple legs 6221 may remain unbentafter they have been inserted through the retention apertures 6252. Incertain embodiments, referring now to FIGS. 186-189, a fastening systemcomprising the staple cartridge 6200 and the retention matrix 6250 mayfurther comprise a plurality of protective caps or covers, such as caps6270, for example, which can be assembled to the staple legs 6221protruding above the retention matrix 6250. In various embodiments, eachcap 6270 can entirely, or at least partially, cover the sharp end of astaple leg 6221 such that the sharp end does not contact tissuepositioned adjacent thereto. In at least one embodiment, referring nowto FIG. 189, each cap 6270 can comprise an aperture 6271 defined thereinwhich can be configured to closely receive a tip of a staple leg 6221therein. In various embodiments, the caps 6270 can be comprised of anelastomeric material, such as silicone, polyisoprene, sanoprene, and/ornatural rubber, for example. In at least one embodiment, the aperture6271 can comprise a perimeter or diameter which is smaller than theperimeter or diameter of the staple leg 6221 inserted therein. In atleast one such embodiment, the aperture 6271 in the protective cap 6270can expand in order to receive the staple leg 6221 therein. In variousalternative embodiments, the caps 6270 may not comprise apertures andthe tips of the staple legs 6221 can be configured to incise the caps6270 as the legs 6221 are inserted therein. In any event, in variousembodiments, each cap 6270 can be seated onto a staple leg 6221 untilthe base 6272 of the cap 6270 abuts, or is positioned adjacent to, thetop surface 6257 of the retention matrix 6250. In various circumstances,the caps 6270 can be configured such that they are seated snugly ontothe tips of the staple legs 6221 such that they are not easily removedtherefrom. In certain embodiments, each cap 6270 can comprise a conical,or at least substantially conical, outer surface, for example. Invarious embodiments, the caps 6270 can comprise any suitable shape, suchas shapes comprising a parabolic, or at least substantially parabolic,outer surface, for example.

In various embodiments, the fastener system described above, forexample, could be deployed using the surgical stapler depicted in FIGS.190-192, for example. In various embodiments, the end effector cancomprise a first jaw, or staple cartridge channel, 6230 which can beconfigured to support the staple cartridge 6200 therein and a second jaw6240 which can be configured to support the retention matrix 6250 andthe plurality of protective caps 6270. Referring primarily to FIG. 190,which illustrates the second jaw 6240 in an open configuration, the jaws6230 and 6240 can be positioned relative to tissue T such that thetissue T is positioned intermediate the retention matrix 6250 and thestaple cartridge 6200. In various embodiments, as discussed above, thestaple cartridge 6200 can further comprise a compressible cartridgebody, such as cartridge body 6210, for example, in which the staples6220 and the alignment matrix 6260 can be positioned. In at least onesuch embodiment, the tissue T can be positioned against a top surface ofthe cartridge body 6210. In certain embodiments, the second jaw 6240 cancomprise a plurality of recesses, or apertures, 6245 configured toreceive the plurality of protective caps 6270 and, in addition, one ormore retention features, or retainers, which can be configured to holdthe retention matrix 6250 in position over the caps 6270. In at leastone such embodiment, the retention matrix 6250 can be configured toretain the caps 6270 in the apertures 6245. In various embodiments,referring now to FIG. 202, each aperture 6245 can be configured toreceive a portion of, or the entirety of, a cap 6270 therein. In certainembodiments, the apertures 6245 can be sufficiently sized and configuredsuch that the caps 6270 can be secured therein by at least one of apress-fit and/or snap fit arrangement, for example. In some embodiments,at least one adhesive could be utilized to secure the caps 6270 in theapertures 6245. In at least one such embodiment, such an adhesive couldbe selected such that caps 6270 can detach from the second jaw 6240after the caps 6270 have been engaged with the staple legs 6221 and thesecond jaw 6240 is moved away from the implanted fastener assembly. Incertain embodiments, referring now to FIG. 203, the second jaw 6240 canfurther comprise at least one cover sheet 6246 which can be assembled tothe second jaw 6240 and can extend over and retain the caps 6270 in theapertures 6245. In at least one such embodiment, at least a portion ofthe cover sheet 6246 can be secured to the jaw 6240 utilizing at leastone adhesive, for example. In use, in at least one embodiment, the coversheet 6246 can be at least partially detached from the jaw 6240 beforethe end effector is inserted into a surgical site. In certainembodiments, the cover sheet 6246 can be comprised of an implantablematerial, such as PDS and/or PGA, for example, which can be incised bythe staple legs 6221 as the staple legs 6221 emerge from the retentionmatrix 6250. In at least one such embodiment, the cover sheet 6246 canbe secured in the fastening system intermediate the covers 6270 and theretention matrix 6250.

Further to the above, referring now to FIG. 191, the jaw 6240 can bemoved from an open position to a closed position in which the tissue Tis positioned against the retention matrix 6250 and the cartridge body6210. In such a position, the retention matrix 6250 may not yet beengaged with the staples 6220. In various embodiments, the jaw 6240 canbe moved between its open position and its closed position by anactuator 6235. In at least one such embodiment, the jaw 6240 cancomprise a distal pin 6243 and a proximal pin 6244 extending therefrom,wherein the distal pin 6243 can slide vertically, or at leastsubstantially vertically, within a distal slot 6233 defined in thecartridge channel 6230, and wherein the proximal pin 6244 can slidevertically, or at least substantially vertically, within a proximal slot6234 which is also defined in the staple cartridge channel 6230. In use,the actuator 6235 can be retracted proximally in order to drive the pins6243 and 6244 into the upper ends of their respective slots 6233 and6234 as illustrated in FIG. 191. In at least one such embodiment, theactuator 6235 can comprise a distal drive slot 6236 and a proximal driveslot 6237, wherein the sidewalls of the drive slots 6236 and 6237 can beconfigured to contact the distal pin 6243 and the proximal pin 6244,respectively, and drive the pins 6243 and 6244 upwardly as the actuator6235 is moved proximally. More particularly, as the actuator 6235 ismoved proximally, the distal pin 6243 can slide up an inclined firstportion 6236 a of the distal drive slot 6236 into an intermediate, orsecond, portion 6236 b and, similarly, the proximal pin 6244 can slideup an inclined first portion 6237 a of the distal drive slot 6237 intoan intermediate, or second, portion 6237 b. As the pins 6243 and 6244are both moved upwardly, the jaw 6240 can be rotated downwardly towardthe tissue T into a closed position.

Further to the above, referring now to FIG. 192, the actuator 6235 canbe pulled further proximally in order to push the second jaw 6240downwardly toward the first jaw 6230, compress the cartridge body 6210,and engage the retention matrix 6250 and the plurality of protectivecaps 6270 with the staple legs of the staples 6220. In at least one suchembodiment, the additional proximal movement of the actuator 6235 cancause the sidewalls of the drive slots 6236 and 6237 to contact the pins6243 and 6244, respectively, and drive the pins 6243 and 6244 downwardlytoward the bottom ends of the slots 6233 and 6234, respectively. In suchcircumstances, the actuator 6235 can be pulled proximally such that,one, the distal pin 6243 exits the second portion 6236 b of the driveslot 6236 and enters into an inclined third portion 6236 c and,similarly, the proximal pin 6244 exits the second portion 6237 b of thedrive slot 6237 and enters into an inclined third portion 6237 c. As thepins 6243 and 6244 are both moved downwardly, the second jaw 6240 canmove downwardly toward the first jaw 6230 into a fired position. In atleast one such embodiment, the second jaw 6240 can be moved downwardlysuch that the retention matrix 6250 remains parallel, or at leastsubstantially parallel, to the top surface of the cartridge body 6210and/or parallel, or at least substantially parallel, to the alignmentmatrix 6260. In any event, once the retention matrix 6250 and theprotective caps 6270 have been engaged with the staple legs 6221 of thestaples 6220, as illustrated in FIG. 194, the second jaw 6240 can bereturned to an open, or an at least substantially open, position. In atleast one such embodiment, the actuator 6235 can be pushed distally inorder to drive the pins 6243 and 6244 to the top ends of the slots 6233and 6234, respectively, and then driven downwardly toward the bottomends of the slots 6233 and 6234 once the pins have passed through theintermediate portions 6236 b and 6237 b of the respective drive slots6236 and 6237. Once the second jaw 6240 has been opened, the first jaw6230 can be detached from the implanted staple cartridge 6200 and thefirst and second jaws 6230, 6240 can be removed away from the implantedfastener assembly, as illustrated in FIG. 193.

Referring to FIG. 192 once again, the reader will note that the pins6243 and 6244 are not illustrated as being seated in the very bottoms oftheir respective slots 6233 and 6234 eventhough the retention matrix6250 and the caps 6270 have been engaged with the staple legs 6221. Suchcircumstances can arise when thick tissue T is positioned between theretention matrix 6250 and the cartridge body 6210. In circumstanceswhere thinner tissue T is positioned between the retention matrix 6250and the cartridge body 6210, referring now to FIG. 195, the pins 6243and 6244 can be drive further downwardly into their respective slots6233 and 6234 as illustrated in FIG. 197. In general, in at least onesuch embodiment, the actuator 6235 can be pulled proximally in order todrive the pins 6243 and 6244 upwardly and downwardly through theprogressions described above and illustrated in FIGS. 195-197 and, owingto the thinner tissue T, the retention matrix 6250 and the protectivecaps 6270 can be driven further onto the staple legs 6221 of the staples6220, as illustrated in FIGS. 198 and 199. In various embodiments, as aresult of the adjustability afforded by the retention matrix 6250, thesame, or at least substantially the same, compressive pressure can beobtained in the fastened tissue regardless of whether the tissuecaptured within the end effector is thick or thin. In certainembodiments, the adjustability afforded by the retention matrix 6250 canallow a surgeon can select whether to apply a larger compressivepressure or a smaller compressive pressure to the tissue by selectingthe depth to which the retention matrix 6250 is seated. In at least onesuch embodiment, the range in which the retention matrix 6250 can beseated onto the staple legs 6221 can be determined by the lengths, orranges, of the slots 6233 and 6234, for example.

In various embodiments, as described above, the protective caps 6270 canbe comprised of a soft or flexible material, for example, which can beconfigured to grip the ends of the staple legs 6221. In certainembodiments, the protective caps 6270 can be comprised of abioabsorbable plastic, polyglycolic acid (PGA) which is marketed underthe trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone(PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which ismarketed under the trade name Monocryl, polycaprolactone (PCL), and/or acomposite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example, and/or abiocompatible metal, such as titanium and/or stainless steel, forexample. As illustrated in FIG. 189, in at least one embodiment, eachcap 6270 can be unconnected to the other caps 6270. In certain otherembodiments, one or more caps 6270 can be mounted to the retentionmatrix 6250. In at least one such embodiment, the caps 6270 can beconnected to the retention matrix 6250 by at least one adhesive, forexample, wherein the apertures 6271 in the caps 6270 can be aligned, orat least substantially aligned, with the retention apertures 6252 in theretention matrix 6270. In various embodiments, referring now to FIG.200, a protective cap, such as a cap 6370, for example, can define aninner cavity, or dome, 6374 which can be configured to receive a tip ofa staple leg 6221, for example, therein. In at least one suchembodiment, the cap 6370 can comprise a bottom 6372 and an aperture 6371extending through the bottom 6372. In various embodiments, the aperture6371 can be defined by one or more deflectable members 6373 which can beconfigured to deflect when the staple leg 6221 is inserted therethrough.In certain embodiments, two or more caps 6370, for example, can beconnected together to form an array of caps 6370. In at least one suchembodiment, referring now to FIG. 201, a plurality of caps 6370 can beconnected together by a sheet of material 6375. In certain embodiments,the sheet 6375 can be sufficiently rigid in order to maintain a desiredarrangement and/or alignment of the caps 6370. In at least oneembodiment, the caps 6370 can be comprised of a biocompatible metal,such as titanium and/or stainless steel, for example, and the sheet 6375can be comprised of a bioabsorbable plastic, polyglycolic acid (PGA)which is marketed under the trade name Vicryl, polylactic acid (PLA orPLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), poliglecaprone25 (PGCL) which is marketed under the trade name Monocryl,polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCLand/or PCL, for example. In various embodiments, a sheet 6375 can becomprised of a bioabsorbable material including an anti-microbial agent,such as colloidal silver and/or triclosan, for example, stored and/ordispersed therein which can be released as the sheet 6375 isbioabsorbed, for example.

In various embodiments, further to the above, the sheet 6375 can beinjection molded around the caps 6370 utilizing an injection moldingprocess, for example, such that the caps 6370 are embedded in the sheet6375. In certain other embodiments, the sheet 6375 can be moldedutilizing an injection molding process, for example, wherein apertures6376 can be formed in the sheet 6375 during the injection moldingprocess and/or after the injection molding process utilizing a stampingprocess, for example. In either event, the caps 6370 can be insertedinto and secured in the apertures 6376 utilizing a press-fit and/orsnap-fit interconnection and/or at least one adhesive. In certainembodiments, each cap 6370 can comprise an annular groove surrounding,or at least partially surrounding, the perimeter of the cap 6370 whichcan be configured to receive the perimeter of an aperture 6376 therein.In certain embodiments, the sheet 6375 can be comprised of a flexibleand/or pliable material which can permit relative movement between thecaps 6370. In at least one such embodiment, the flexible sheet 6375 canbe comprised of a rubber, plastic, and/or silicone material, forexample, and the caps 6370 can be comprised of a rigid material, such asmetal, for example. In at least one such embodiment, similar to theabove, the flexible material can be molded around the caps 6370. Incertain embodiments, the caps 6370 can be pressed into a pre-moldedsheet 6375, for example. In various embodiments, the durometer of theflexible material can be selected to provide a desired stiffness of thesheet 6375. In certain embodiments, the sheet 6375 can be configuredsuch that it comprises a flexible band. In any event, the sheet 6375 canfacilitate the assembly of the caps 6370 into an end effector as aplurality of the caps 6370 can be positioned and/or alignedsimultaneously within the end effector. Furthermore, the sheet 6375connecting the caps 6370, once implanted, can strengthen or bolster thetissue along the staple line, for example. In addition to or in lieu ofa sheet connecting the caps 6370, the caps 6370 can be connectedtogether by a plurality of links. In at least one such embodiment, suchlinks can be flexible and can permit relative movement between the caps6370.

In various embodiments, referring now to FIGS. 204 and 205, a protectivecap, such as cap 6470, for example, can comprise a forming surface whichcan be configured to deform a tip of a staple leg. In at least one suchembodiment, the cap 6470 can comprise a base 6472 which can include anaperture 6471 extending therethrough. In various embodiments, theaperture 6471 can be configured to closely receive a staple leg, such asa staple leg 6221, for example, therein. In at least one embodiment, theaperture 6471 can be defined by a diameter or perimeter which can beequal to or larger than the diameter or perimeter of the staple leg6221. In various embodiments, the cap 6470 can further comprise acavity, or dome, 6474 which can be configured to receive the tip of thestaple leg 6221 as it is inserted into the cap 6470. Referring primarilyto FIG. 205, the cap 6470 can further comprise an anvil, or formingsurface, 6473 which can be configured to deflect and deform the stapleleg 6221. In various circumstances, the forming surface 6473 can becurved and/or concave, for example, and can be configured to curl thestaple leg 6221 as it is inserted into the cap 6470. In certainembodiments, the staple leg 6221 can be sufficiently deformed such thatit cannot be withdrawn through the aperture 6471 and, as a result, thecap 6470 can become locked to the staple leg 6221. In at least one suchembodiment, the base 6472 of the cap 6470 can define a lip extendingaround the aperture 6471 which can prevent the deformed staple leg 6221from being removed from the cavity 6474. In various circumstances, as aresult of the above, one or more caps 6470 can prevent, or inhibit, aretention matrix, such as retention matrix 6250, for example, frombacking up or being disengaged from the staples 6220. In variousembodiments, although not illustrated, the cap 6470 can besymmetrically, or at least substantially symmetrically, formed, and theaperture 6471 can be located along a central axis 6479 extending throughthe cap 6470. In various alternative embodiments, referring again toFIG. 204, the aperture 6471 can be offset with respect to the centralaxis 6479. In at least one such embodiment, the offset aperture 6471 canallow the staple leg 6221 to contact a side of the forming surface 6473and curl over to the other side of the forming surface 6473 instead ofcontacting the center of the forming surface 6473, as may occur inembodiments comprising a centered aperture 6471 mentioned above.

In various embodiments, as discussed above, a retention matrix, such asretention matrix 6250, for example, can be comprised of a sheet ofmaterial and a plurality of retention apertures 6252 extendingtherethrough. In at least some embodiments, the sheet of materialcomprising the retention matrix 6250 can be rigid or substantiallyinflexible. In certain other embodiments, a retention matrix can becomprised of an array of retention matrix elements and a plurality offlexible connectors, or links, connecting the retention matrix elements.In various embodiments, referring now to FIG. 206, a retention matrix,or a portion of retention matrix, 6550 can comprise a plurality ofelement bodies 6505 which can be connected together by one or moreconnecting links 6507. In at least one embodiment, each element body6505 can comprise a plurality of deformable members 6553 which define aretention aperture 6552 therein. In certain embodiments, the elementbodies 6505 and the connecting links 6507 of a retention matrix 6550 canbe integrally formed and can comprise a unitary piece of material. Invarious embodiments, the retention matrix 6550 can be stamped or cast,for example, from a metal material, such as titanium and/or stainlesssteel, for example. In at least one embodiment, the retention matrix6550 can be comprised of plastic, such as polyetheretherketone (PEEK),polypropylene which is marketed under the trade name Prolene, polyester,polyethylene terephthalate which is marketed under the trade namesEthibond and Mersilene, polyvinylidene fluoride, polyvinylidenefluoride-co-hexafluoropropylene, poly hexafluoropropylene-VDF which ismarketed under the trade name Pronova, and/or long-chain aliphaticpolymers Nylon 6 and Nylon 6,6 which are marketed under the trade namesEthilon & Nurolon, for example, and can be formed by an injectionmolding process, for example. In certain embodiments, the element bodies6505 may not be integrally formed with the connecting links 6507. Invarious embodiments, a plurality of singular element bodies 6505 can beproduced which are subsequently connected together and embedded in aretention matrix. In at least one such embodiment, the element bodies6505 can be stamped from a metal material, such as titanium and/orstainless steel, for example, and placed in a plastic injection moldwherein a plastic material can be injected into the mold to form, one, arim 6506 of material surrounding, or at least partially surrounding, theelement bodies 6505 and, two, connecting links 6507 extending from therims 6506. In certain other embodiments, one or more connector latticescan be formed comprising apertures defined within a plurality of rims6506 wherein each such aperture can be configured to receive an elementbody 6505 therein. In at least one embodiment, each element body 6505can comprise a circular, or at least substantially circular, outerperimeter and, similarly, each rim 6506 can define a circular, or atleast substantially circular, aperture therein, wherein the diameter ofthe aperture can be equal to or smaller than the diameter of the elementbody 6505. In at least one such embodiment, the element bodies 6505 canbe press-fit or embedded into the apertures in the rims 6505. In certainembodiments, the element bodies 6505 can be secured in the aperturesutilizing at least one adhesive.

In various embodiments, further to the above, a retention matrix cancomprise a plurality of element bodies 6505 and a plurality ofconnecting links 6507 which can connect the element bodies 6505 in anysuitable array, such as those illustrated in FIGS. 207-210, for example.Regardless of the pattern of the array, in various embodiments, theconnecting links 6507 can be configured to allow the element bodies 6505and the retention apertures 6552 to move relative to one another. In atleast one such embodiment, the lattice of element bodies 6505 andconnecting links 6507 comprising the retention matrix 6550, once engagedwith tissue, can be configured to stretch, twist, contract, and/orotherwise flex in order to permit at least some movement within thetissue yet, at the same time, resist larger movements thereof. Invarious embodiments, each connecting link 6507 can comprise a flexiblemember configured to stretch, twist, and/or contract in order to permitthe retention matrix 6550 to flex intermediate the matrix retentionelements 6505, for example. Referring again to FIG. 206, each link 6507extending from a rim 6506 can be defined by a width which is narrowerthan the width of the element body 6505 and/or the rim 6506. In certainembodiments, referring to FIGS. 207-210, one or more links 6507 cancomprise straight portions which extend along a line between adjacentelement bodies 6506, for example. In at least one such embodiment, eachlink 6507 can comprise a first end attached to a first rim 6506 and asecond end attached to a second rim 6506. In certain embodiments,referring once again to FIG. 206, two or more links 6507 can beconnected to one another. In at least one such embodiment, two or morelinks 6507 can be connected at an intermediate hinge 6509, for example.In various embodiments, the hinge 6509 can comprise a reduction incross-sectional thickness in one or more directions as compared to thecross-sectional thickness of the links 6507 which can permit theconnected links 6507 to move relative to each other, for example. Incertain embodiments, the retention matrix 6550 can further comprisehinges 6508 which can connect the links 6507 to the rims 6506 and permitrelative movement between the links 6507 and the rims 6506. Similar tohinges 6509, hinges 6508 can comprise a reduction in cross-sectionalthickness in one or more directions as compared to the cross-sectionalthickness of the links 6507, for example.

In various embodiments, further to the above, the connected links 6507can extend in different directions. In at least one such embodiment, afirst link 6507 can extend in a first direction and a second link 6507can extend in a second direction, wherein the first direction can bedifferent than the second direction. In certain embodiments, the firstlink 6507 can extend along a first line and the second link 6507 canextend along a second line, wherein the first line and the second linecan intersect each other at an angle, such as approximately 30 degrees,approximately 45 degrees, approximately 60 degrees, and/or approximately90 degrees, for example. In various embodiments, the hinges 6508 and/orhinges 6509 can comprise living hinges which can permit the links 6507to move relative to each other a number of times without breaking. Incertain embodiments, the hinges 6508 and/or hinges 6509 can comprisefrangible, or easily-breakable, portions which can break when flexed toofar and/or flexed too many times. In at least one such embodiment, suchfrangible portions can permit one or more portions of the retentionmatrix 6550 to break away from another portion of the retention matrix6550. In various embodiments, the hinges 6508 and/or hinges 6509, forexample, can comprise sections of the retention matrix 6550 which areeasier to incise than the other portions of the retention matrix 6550.More particularly, an implanted retention matrix, and the tissuefastened by the implanted retention matrix, may oftentimes by incised bya cutting member for various reasons and, in order to facilitate suchcross-cutting, the hinges 6508 and/or hinges 6509 can provide avenues,or thin sections, through which a cutting member can more easily passthrough the retention matrix 6550, for example. In various embodiments,further to the above, the connecting links 6507 can comprise one or morecoined features or material upsets, for example, defined therein whichcan facilitate the bending, breakage, and/or incision of the connectinglinks 6507.

In various embodiments, a retention matrix can comprise a plurality ofretention matrix elements, such as matrix element bodies 6505, forexample, which can be embedded in a flexible sheet, or band, ofmaterial. In at least one embodiment, a flexible sheet of material canbe formed from a bioabsorbable, elastomeric material, such as silicone,for example, wherein the flexible sheet can be produced with a pluralityof apertures defined therein. In at least one such embodiment, a solidflexible sheet can be molded and a plurality of apertures can be punchedout of the flexible sheet. In various alternative embodiments, theflexible sheet can be molded and the apertures defined therein can beformed during the molding process. In either event, the retention matrixelements 6505, for example, can be inserted into and retained within theflexible sheet. In certain other embodiments, similar to the above, theflexible sheet can be formed around the matrix elements 6505. In atleast one embodiment, the flexible sheet can be comprised of a wovenmesh, for example, and/or any other suitable material. Such a wovenmesh, further to the above, may be easy to cross-cut.

In various embodiments, referring now to FIGS. 211 and 212, a fastenersystem comprising a retention matrix, such as retention matrix 6250, forexample, can further comprise a cover, such as cover 6670, for example,which can cover the tips of the staple legs 6221 when they extend abovethe top surface 6257 of the retention matrix 6250. In variousembodiments, the cover 6670 can be attached to the retention matrix6250. In certain embodiments, the cover 6670 and/or the retention matrix6250 can comprise retention features which can be configured to retainthe cover 6670 to the retention matrix 6250. In at least one embodiment,at least one adhesive can be utilized to adhere the cover 6670 to theretention matrix 6250. In at least one embodiment, the cover 6670 can becomprised of a single layer, although the cover 6670 is illustrated ascomprising two layers as described in greater detail further below. Invarious embodiments, referring primarily to FIG. 212, the tips of thestaple legs 6221 can extend through a bottom surface 6673 of the cover6670; however, the cover 6670 can comprise a sufficient thickness suchthat the staple tips do not extend through the top surface 6675 of thecover 6670. In at least one such embodiment, as a result, the tips ofthe staple legs 6221 may not protrude from the cover 6670. In variousembodiments, the cover 6670 can comprise a plurality of layers. In atleast one such embodiment, the cover 6670 can comprise a first layer6671 and a second layer 6672. In at least one embodiment, the firstlayer 6671 and the second layer 6672 can be attached to one anotherwherein, in at least one embodiment, the second layer 6672 can comprisea bottom surface 6676 which is adhered to the first layer 6671. Invarious embodiments, the first layer 6671 and the second layer 6672 cancomprise different thicknesses while, in certain embodiments, they cancomprise the same thickness. In at least one embodiment, the first layer6671 and the second layer 6672 can comprise substantially the same widthand/or length. In alternative embodiments, the layers 6671 and 6672 cancomprise different widths and/or lengths.

In various embodiments, further to the above, the first layer 6671 canbe comprised of a compressible foam, mesh material, and/or hydrogel, forexample, which can be incised by the staple legs 6211. In at least oneembodiment, the second layer 6672 can be comprise of a tougher material,or skin, such as PGA and/or PDS, for example, and/or any suitablebuttress material. In at least one such embodiment, the staple legs 6221can be configured to penetrate the first layer 6671; however, in variousembodiments, the staple legs 6221 may be unable to penetrate the secondlayer 6672. In certain embodiments, the second layer 6672 can becomprised of a material having a sufficient resiliency and/or toughnesswhich can permit the second layer 6672 to be contacted and displaced bythe staple leg 6221 but not be incised, or only marginally incised, bythe staple tip of the staple leg 6221. Although not illustrated, a covercan comprise more than two layers wherein one or more of such layers maybe penetration-resistant. In use, in at least one such embodiment, theretention matrix 6250 can be positioned against the tissue to befastened and pushed downwardly such that the staple legs 6221 of thestaples 6220 are pushed through the tissue T and the retention apertures6252 in the retention matrix 6250 and enter into the first layer 6271 ofthe cover 6270. In various embodiments, the tips of the staple legs 6221may not enter, or at least substantially enter, into the second layer6272 of the cover 6270. After the retention matrix 6250 has beensuitably positioned, the jaw 6240 can be opened and the cover 6670 andthe retention matrix 6250 can detach from the jaw 6240 as illustrated inFIG. 211. As illustrated in FIG. 211, a jaw 6640 can be configured tohold more than one retention matrix 6250 and cover 6670. In at least onesuch embodiment, the jaw 6640 can comprise two channels 6679 which eachcan be configured to receive a cover 6670 therein and a retention matrix6250 positioned thereover such that the tissue-contacting surface 6251of each retention matrix 6250 depends downwardly from the bottom of thejaw 6240. In at least one such embodiment, a retention matrix 6250 and acover 6270 can be housed in the jaw 6640 on each side of a knife slot6678. In use, both retention matrices 6250 and covers 6670 can bedeployed simultaneously and/or to the same depth with respect toopposing staple cartridges, such as cartridges 6200, for example,positioned thereacross. Thereafter, in various embodiments, the fastenedtissue can be incised along a cutting line by a cutting member thattraverses the knife slot 6678 wherein the jaw 6640 can then bere-opened. In certain embodiments, the covers 6670 may not be attachedto the retention matrix 6250. In at least one such embodiment, thecovers 6670 can be positioned in the channels 6679 and can be retainedin the channels 6679 by the retention matrices 6250 which can be securedto the jaw 6640. In various embodiments, the each retention matrix 6250can be wider and/or longer than their respective covers 6670 such thatthe retention matrices 6250 can retain the entirety of their covers 6670in position. In certain embodiments, each retention matrix 6250 cancomprise the same width and/or length as their respective cover 6670,for example.

In various embodiments, as described above, a fastener system cancomprise a layer of material which can be attached to a retentionmatrix, such as retention matrix 6250, for example. In at least oneembodiment, referring now to FIG. 215, a layer of material 6870 can beattached to the bottom surface 6251 of the retention matrix 6250. Incertain embodiments, the layer 6870 and/or the retention matrix 6250 cancomprise retention features which can be configured to retain the layer6870 to the retention matrix 6250. In at least one embodiment, at leastone adhesive can be utilized to adhere the layer 6870 to the retentionmatrix 6250. In any event, the layer 6870 can comprise a bottom, ortissue-contacting, surface 6873 which can be configured to contact thetissue T when the retention matrix 6250 is moved downwardly toward thestaples 6220 to engage the retention apertures 6252 with the staple legs6221. In at least one such embodiment, the layer 6870 can be comprisedof a compressible material, such as a bioabsorbable foam, for example,which can be compressed between the bottom surface 6251 of the retentionmatrix 6250 and the tissue T. In various embodiments, the layer 6870 canfurther comprise at least one medicament stored and/or absorbed thereinwhich can be expressed from the layer 6870 as the layer 6870 iscompressed. In at least one embodiment, the medicament can comprise atleast one tissue sealant, hemostatic agent, and/or anti-microbialmaterial, such as ionized silver and/or triclosan, for example. Invarious embodiments, the compression of the layer 6870 can squeeze themedicament from the layer 6870 such that the entirety of, or at least asignificant portion of, the surface of the tissue T is covered with themedicament. Furthermore, as the layer 6870 is compressed and the staplelegs 6221 penetrate the tissue T and the layer 6870, the medicament canflow down the staple legs 6221 and treat the tissue that has just beenincised by the staple legs 6221, for example. In various embodiments,the body of the retention matrix 6250 can comprise a first layer whichis comprised of a biocompatible material, such as titanium and/orstainless steel, for example, and the bottom layer 6870 can comprise asecond layer comprised of a bioabsorbable material, such as oxidizedregenerated cellulose (ORC), biologically active agents like fibrinand/or thrombin (either in their liquid state or freeze dried),glycerin, absorbable porcine gelatin in either flue or foamconfigurations, and/or anti-microbials, such as ionized silver and/ortriclosan, for example. Additional bioabsorbable materials can compriseSurgicel Nu-Knit, Surgicel Fibrillar, collagen/ORC which is a hybridwith a built in collagen matrix and is marketed under the trade namePromogran, polyglycolic acid (PGA) which is marketed under the tradename Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS),polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketedunder the trade name Monocryl, polycaprolactone (PCL), and/or acomposite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example. Althoughonly one layer 6870 is illustrated in FIG. 215, any suitable number oflayers could be used. In at least one embodiment, a first layercomprising a first medicament could be attached to the retention matrix6250 and a second layer comprising a second, or different, medicamentcould be attached to the first layer. In at least one such embodiment, aplurality of layers could be used wherein each layer can comprise adifferent medicament and/or a different combination of medicamentscontained therein.

In various embodiments, referring now to FIG. 213, a fastener system cancomprise a layer of material 6770 attached to the bottom surface 6251 ofthe retention matrix 6250. In certain embodiments, the layer 6770 and/orthe retention matrix 6250 can comprise retention features which can beconfigured to retain the layer 6770 to the retention matrix 6250. In atleast one embodiment, at least one adhesive can be utilized to adherethe layer 6770 to the retention matrix 6250. In any event, the layer6770 can comprise a bottom, or tissue-contacting, surface 6773 which canbe configured to contact the tissue T when the retention matrix 6250 ismoved downwardly toward the staples 6220 to engage the retentionapertures 6252 with the staple legs 6221. In at least one suchembodiment, the layer 6770 can be comprised of a compressible material,such as a bioabsorbable foam, for example, which can be compressedbetween the surface 6251 of the retention matrix 6250 and the tissue T.In various embodiments, the layer 6770 can further comprise one or moreencapsulations, or cells, 6774 which can be configured to store at leastone medicament therein. In certain embodiments, referring to FIG. 214,the encapsulations 6774 can be aligned, or at least substantiallyaligned, with the retention apertures 6252 such that, when the staplelegs 6221 are pushed through the tissue T and the layer 6770, the staplelegs 6221 can puncture and/or otherwise rupture the encapsulations 6774.After the encapsulations 6774 have been ruptured, the at least onemedicament M stored in the encapsulations 6774 can flow out onto thetissue T. In at least one such embodiment, the medicament M can comprisea fluid which can flow or wick down the staple legs 6221 and treat thetissue T that was just incised by the staple legs. As a result of theabove, the medicament stored within the encapsulations 6774 can providea localized treatment to the tissue. In certain embodiments, theencapsulations 6774 in the sheet 6770 can comprise different medicamentsstored therein. For example, a first group of encapsulations 6774 cancomprise a first medicament, or a first combination of medicaments,stored therein and a second group of encapsulations can comprise adifferent medicament, or a different combination of medicaments, storedtherein. In various embodiments, the layer 6770 can be comprised of aflexible silicone sheet and the encapsulations 6774 can represent voidsin the silicone sheet. In at least one such embodiment, the siliconesheet can comprise two layers that can be attached to one anotherwherein the encapsulations 6774 can be defined between the two layers.In various embodiments, the layer 6770 can comprise one or more thinsections or weakened portions, such as partial perforations, forexample, which can facilitate the incision of the layer 6770 and therupture of the encapsulations 6774 by the legs 6221. In certainembodiments, at least a portion of the encapsulations 6774 can bepositioned within domes 6777, wherein the domes 6777 can extend upwardlyfrom the sheet 6770. In at least one such embodiment, the domes 6777and/or at least a portion of the encapsulations 6774 can be positionedwithin the pockets 6201 formed within the retention matrix 6250. Incertain embodiments, the encapsulations 6774 may comprise discrete cellswhich are unconnected to each other. In certain other embodiments, oneor more of the encapsulations 6774 can be in fluid communication witheach other via one or more passageways, conduits, and/or channels, forexample, extending through the layer 6770. The disclosure of U.S. Pat.No. 7,780,685, entitled ADHESIVE AND MECHANICAL FASTENER, which issuedon Aug. 24, 2010, is hereby incorporated by reference in its entirety.

In various embodiments, further to the above, a staple cartridgecomprising a cartridge body, staples, and/or an alignment matrix thereincan be loaded into a first jaw of an end effector and, similarly, aretention matrix and/or one or more covers can be loaded into a secondjaw of the end effector. In certain embodiments, referring now to FIG.216, an instrument, such as cartridge loader 6990, for example, can beused to insert two or more fastener cartridges into an end effector atthe same. In at least one embodiment, the cartridge loader 6990 cancomprise a handle 6991 and a cartridge carrier 6992, wherein thecartridge carrier 6992 can comprise a first retention portion configuredto retain the cartridge body 6210 of the staple cartridge 6200 theretoand, in addition, a second retention portion configured to retain acartridge body 6980 which supports, one, a plurality of protective caps6270 therein and, two, a retention matrix 6250 along the bottom surfacethereof, for example. In various embodiments, the first and secondretention portions can each comprise one or more retention membersconfigured to releasably engage the cartridge bodies 6210 and 6980. Inuse, referring now to FIGS. 217 and 218, an end effector can comprise afirst, or bottom, jaw 6230 and a second, or top, jaw 6940, wherein thestaple cartridge 6200 can be loaded into the first jaw 6230 and thecartridge body 6980 can be loaded into the second jaw 6940. In variouscircumstances, the top jaw 6940 can be rotated from an open position(FIG. 217) to a closed position (FIG. 218) by an actuator 6235, whereinthe operation of the actuator 6235 is described above and is notrepeated herein for the sake of brevity. Once the top jaw 6940 is in itsclosed position, referring now to FIG. 218, the distal end 6993 of thecartridge carrier 6992 can be inserted into the end effector such thatthe staple cartridge 6200 is slid through the distal end 6938 of thefirst jaw 6930 and into a first attachment portion, or channel, 6939 inthe first jaw 6230. Similarly, the distal end 6993 of the cartridgecarrier 6992 can be inserted into the end effector such that thecartridge body 6980 is slid through the distal end 6948 of the secondjaw 6940 and into a second attachment portion, or channel, 6949 in thesecond jaw 6940. A surgeon, or other clinician, holding the handle 6991of the cartridge loader 6990 can push the staple cartridge 6200 and thecartridge body 6980 through the channels 6939 and 6949, respectively,until the staple cartridge 6200 and the cartridge body 6980 are fullyseated therein.

As the staple cartridge 6200 and the cartridge body 6980 are beingseated, the staple cartridge 6200 and the cartridge body 6980 can eachengage one or more retention portions in their respective jaws 6230 and6940, as described in greater detail further below. In any event, oncethe staple cartridge 6200 and the cartridge body 6980 have been seated,referring now to FIG. 219, the cartridge loader 6990 can be detachedfrom the staple cartridge 6200 and the cartridge body 6980 and removedfrom the end effector. In at least one such embodiment, the retentionforce holding the staple cartridge 6200 in the first jaw 6230 can begreater than the retention force holding the staple cartridge 6200 tothe cartridge carrier 6992 such that, as the cartridge carrier 6992 ispulled distally out of the end effector, the staple cartridge 6200 canremain behind in the first jaw 6230. Similarly, the retention forceholding the cartridge body 6980 in the second jaw 6940 can be greaterthan the retention force holding the cartridge body 6940 to thecartridge carrier 6992 such that, as the cartridge carrier 6992 ispulled distally out of the end effector, the cartridge body 6940 canremain behind in the second jaw 6940. Once the cartridge loader 6990 hasbeen removed from the end effector, the loaded first jaw 6230 and theloaded second jaw 6940 can be positioned relative to the tissue T thatis to be stapled. Referring now to FIG. 220, the second jaw 6940 can bemoved from an open position (FIG. 219) to a fired position (FIG. 220) inorder to engage the retention matrix 6250 and the plurality ofprotective caps 6270 carried by the cartridge body 6980 with the staples6220 positioned within the staple cartridge 6200.

Referring now to FIGS. 221 and 222, the second jaw 6940 can be re-openedand the plurality of protective caps 6270 and the retention matrix 6250can detach from the cartridge body 6980 such that the caps 6270 and theretention matrix 6250 can remain engaged with the tissue T and thestaple cartridge 6200. In at least one embodiment, the cartridge body6980 can comprise a plurality of pockets in which the plurality of caps6270 can be removably positioned and one or more retention slotsconfigured to removably retain the retention matrix 6250 thereto. Invarious embodiments, the retention members of the second jaw 6940engaged with the cartridge body 6980 can retain the cartridge body 6980in the second jaw 6940 after the second jaw 6940 has been opened. Incertain embodiments, the cartridge body 6980 can be configured to tearas the second jaw 6940 is opened such that a portion of the cartridgebody 6980 is implanted with the caps 6270 and the retention matrix 6250and a portion of the cartridge body 6980 remains in the second jaw 6940.Similarly, referring again to FIGS. 221 and 222, the retention membersof the first jaw 6230 engaged with the cartridge body 6210 can retainthe cartridge body 6210 in the first jaw 6230 after the second jaw 6940has been opened. In certain embodiments, the cartridge body 6210 can beconfigured to tear as the first jaw 6230 is pulled away from theimplanted cartridge 6200 such that a portion of the cartridge body 6210is implanted with the staples 6220 and alignment matrix 6260 and aportion of the cartridge body 6210 remains in the first jaw 6230. Invarious embodiments, referring now to FIGS. 223-225, a staple cartridge,such as staple cartridge 6900, for example, can comprise one or morelongitudinal retention slots 6913 extending along the length of thecartridge body 6910 which, when the staple cartridge 6900 is insertedinto a jaw 6930, for example, can be configured to receive one or morelongitudinal retention rails 6916 extending from the jaw 6930 therein.In use, in at least one embodiment, an end of the retention slots 6913can be aligned with the distal ends of the retention rails 6916 beforethe staple cartridge 6900 is slid through the distal end 6938 of theretention channel 6939, for example.

In various embodiments, referring again to FIG. 225, the jaw 6940 cancomprise two retention channels 6949, wherein each retention channel6949 can be configured to receive a cartridge body 6980 comprising aplurality of caps 6270 and a retention matrix 6250 therein. In certainembodiments, each cartridge body 6980 can comprise one or morelongitudinal retention shoulders 6917 which can be configured to be slidalong one or more longitudinal retention rails 6918 of the second jaw6940 as the cartridge bodies 6980 are inserted into their respectiveretention channels 6949 in jaw 6940. In various embodiments, theretention rails 6918 and the retention shoulders 6917 can co-operate toretain the cartridge body 6980 in the second jaw 6940 as the cartridgebodies 6980 are detached from the caps 6270 and the retention matrix6250 stored therein. In various embodiments, referring now to FIG. 224,the second jaw 6940 can further comprise one or more distal bumps, orretention members, 6915 extending therefrom which can be configured toremovably lock the cartridge bodies 6980 in their respective retentionchannels. In at least one such embodiment, the second jaw 6940 cancomprise a distal bump 6915 configured and positioned relative to eachretention channel 6949 such that each cartridge body 6980 can flexaround the bumps 6915 as the cartridge bodies 6980 are being insertedinto the channels 6949 wherein, just as the cartridge bodies 6915 arebeing fully seated in the channels 6949, the distal ends of thecartridge bodies 6980 can clear and snap over the bumps 6915. In orderto remove the cartridge bodies 6980 after they have been expended, asdescribed above, the cartridge bodies 6980 can be pulled back over thebumps 6915 and removed from the retention channels 6949. Similar to theabove, the first jaw 6930 can comprise one or more distal retentionbumps 6914 extending therefrom which can be configured to be received inone or more retention grooves, or slots, 6912 (FIG. 223) in thecartridge body 6910 when the staple cartridge 6900 has been fullyseated.

In various embodiments, further to the above, a first fastener cartridgecomprising a plurality of first fasteners positioned therein can bepositioned in a first jaw of a surgical fastening device and a secondfastener cartridge comprising a plurality of second fasteners positionedtherein can be positioned in a second jaw of the surgical fasteningdevice. In use, the first jaw and/or the second jaw can be moved towardthe other in order to engage the first fasteners with the secondfasteners and secure tissue therebetween. In certain embodiments, thefirst fastener cartridge and the second fastener cartridge can beengaged with each other as the first fasteners are engaged with thesecond fasteners. In at least one embodiment, the body of the firstfastener cartridge can be comprised of a first compressible material andthe body of the second fastener cartridge can be comprised of a secondcompressible material, wherein the first body and/or the second body canbe compressed against the tissue being fastened. After the tissue hasbeen fastened, the first jaw can be moved away from the implanted firstfastener cartridge and the second jaw can be moved away from theimplanted second fastener cartridge. Thereafter, the first jaw can bereloaded with another first fastener cartridge, or the like, and thesecond jaw can be reloaded with another second fastener cartridge, orthe like, and the surgical fastening instrument can be reused. Whilestaples can be used in some embodiments, other embodiments areenvisioned comprising other types of fasteners, such as two-partfasteners which are locked together when they are engaged with oneanother, for example. In at least one such embodiment, the firstfastener cartridge can comprise a first storage portion for storing thefirst fastener portions and the second fastener cartridge can comprise asecond storage portion for storing the second fastener portions. Invarious embodiments, the fastening systems described herein can utilizefasteners comprising any suitable type of material and/or form. Incertain embodiments, the fasteners can comprise penetrating members.Such penetrating members could be comprised of a polymer, a composite,and/or a multi-layered substrate, for example. An example of amulti-layered substrate could be a wire or a sheet substrate with anelastomeric or polymeric coating. It could be a thin sheet formed suchthat penetrating members are oriented perpendicular, or at leastsubstantially perpendicular, to the connecting member. The penetratingmembers could comprise a rectangular profile, semi-circular profile,and/or any beam profile. In various embodiments, the fasteners describedherein can be manufactured utilizing any suitable process, such as awire extruding process, for example. Another possibility is the use ofmicrofabrication to create hollow penetrating members. These penetratingmembers could be fabricated from a process which is different than awire extruded process and could use a combination of materials.

As described above, the tips of staple legs protruding through aretention matrix can be covered by one or more caps and/or covers. Incertain embodiments, the tips of the staple legs can be deformed afterthey have been inserted through the retention matrix. In at least oneembodiment, a jaw holding the retention matrix can further compriseanvil pockets positioned above and/or aligned with the retentionapertures which can be configured to deform the staple legs as theyprotrude above the retention matrix. In various embodiments, the staplelegs of each staple can be curled inwardly toward each other and/ortoward the center of the staple, for example. In certain otherembodiments, one or more of the staple legs of a staple can be curledoutwardly away from the other staple legs and/or away from the center ofthe staple. In various embodiments, regardless of the direction in whichthe staple legs are curled, the tips of the staple legs can contact thebody of the retention matrix and may not re-enter the tissue that hasbeen fastened by the staples. In at least one embodiment, thedeformation of the staple legs after they have passed through theretention matrix can lock the retention matrix in position.

In various embodiments, referring now to FIGS. 226 and 227, a surgicalstapling instrument, such as surgical stapler 7000, for example, cancomprise a first jaw 7030 and a second jaw 7040, wherein the second jaw7040 can be moved toward and away from the first jaw 7030 by themovement of actuator 6235. The operation of actuator 6235 is describedabove and is not repeated herein for the sake of brevity. In variousembodiments, the first jaw 7030 can comprise a distal end 7031 and aproximal end 7032, wherein the first jaw 7030 can define a channelextending between the distal end 7031 and the proximal end 7032 which isconfigured to receive a staple cartridge. For the purposes ofillustration, the cartridge body of such a staple cartridge is notdepicted in FIG. 226, although such a staple cartridge can comprise acartridge body, staples 6220 positioned within the cartridge body, andstaple drivers 7012 positioned underneath the staples 6220. In certainembodiments, although not illustrated in FIG. 226 for the sake ofclarity, the second jaw 7040 can be configured to hold a retentionmatrix, such as retention matrix 6250, for example, over the staples6220 and/or move the retention matrix into engagement with the legs ofthe staples 6220 as described above. In at least one embodiment, thesurgical stapler 7000 can further comprise a sled 7010 positioned in thefirst jaw 7030 which can be slid from the distal end 7031 of the firstjaw 7030 toward the proximal end 7032, for example, and lift the stapledrivers 7012, and the staple 6220 supported thereon, toward theretention matrix and the second jaw 7040. In various other embodiments,the sled 7010 can be moved from the proximal end 7032 toward the distalend 7031 in order to deploy the staples 6020, for example. In at leastone embodiment, the sled 7010 can comprise one or more inclined ramps,or cams, 7011 which can be configured to slide underneath the stapledrivers 7012 and lift the staple drivers 7012 upwardly. In variousembodiments, the surgical stapler 7000 can further comprise a pull, orpush, rod operably coupled to the sled 7010 which can be movedproximally and/or distally by an actuator located on a handle and/orshaft of the surgical stapler 7000, for example.

In various embodiments, referring again to FIG. 226, the second jaw 7040of the surgical stapler 7000 can comprise a frame 7041, a distal end7048, and a proximal end 7049 positioned opposite the distal end 7048.In certain embodiments, the second jaw 7040 can further comprise a guidesystem comprising one or more guide rails, such as guide rails 7045 and7046, for example, extending along the longitudinal axis of the frame7041 which, as described in greater detail further below, can beconfigured to guide one or more anvils, or cams, which can engage anddeform the staple legs of the staples 6220 after the staple legs 6221 ofthe staples 6220 have passed through the retention matrix. In at leastone such embodiment, the guide rails 7045 and 7046 can comprise a guidewire or cable which extends along a top portion or surface of the frame7041, around a distal post 7047, and back along the top portion orsurface of the frame 7041, for example. In various embodiments, asmentioned above and referring primarily now to FIGS. 228 and 230, thesecond jaw 7040 can further comprise one or more anvils, or cams, suchas first anvil 7050 and second anvil 7060, for example, which can bemoved longitudinally along the second jaw 7040 in order to deform thelegs of the staples 6220 after they have passed through the retentionmatrix. In at least one embodiment, the surgical stapler 7000 canfurther comprise a first anvil driver, or actuator, 7051 connected toand/or operably coupled to the first anvil 7050 which can be configuredto pull the first anvil 7050 proximally and/or push the first anvil 7050distally. Similarly, in at least one embodiment, the surgical stapler7000 can further comprise a second anvil driver, or actuator, connectedto and/or operably coupled to the second anvil 7060 which can beconfigured to push the second anvil 7060 distally and/or pull the secondanvil 7060 proximally. In various embodiments, the first anvil 7050 cancomprise guide slots 7052 and the second anvil 7060 can comprise guideslots 7062 which can each be configured to slidably receive guide rail7045 or guide rail 7046 therein. In at least one such embodiment, theguide rails 7045 and 7046 can be closely received within the guide slots7052 and 7062 such that relative lateral, or side-to-side, movementtherebetween can be prevented, or at least limited.

In certain embodiments, further to the above, the first anvil 7050 canbe pulled proximally and the second anvil 7060 can be pulled distally.In at least one embodiment, referring to FIG. 226, the guide rails 7045and 7046 and the distal post 7047 can comprise a pulley systemconfigured to pull the second anvil 7060 distally and/or pull the secondanvil 7060 proximally. In at least one such embodiment, the guide rail7045 and the guide rail 7046 can comprise a continuous wire or cableextending around the distal post 7047, wherein a portion of thecontinuous wire can be pulled in order to cycle the wire around thedistal post 7047. In various embodiments, the guide rail 7046, forexample, can be mounted to the second anvil 7060 such that, when thecontinuous cable is cycled in a first direction, the second anvil 7060can be pulled distally toward the distal end 7048 of the jaw 7040 and,when the continuous cable is cycled in a second, or opposite, direction,the second anvil 7060 can be pulled proximally toward the proximal end7049. In at least one embodiment, referring now to FIG. 228, the guiderail 7046 can be secured within a guide slot 7062 such that a pullingforce can be transmitted therebetween. In at least one such embodiment,the guide rail 7045 can be configured to slide within the other guideslot 7062. In various embodiments, the first anvil 7050 may operateindependently of the second anvil 7060 and the pulley system and theguide slots 7052 defined in the first anvil 7050 may be configured toslidably receive the guide rails 7045 and 7046 such that relativemovement is permitted therebetween. In various embodiments, thecontinuous cable comprising guide rails 7045 and 7046 can besufficiently flexible in order to accommodate the opening and closing ofthe top jaw 7040. The continuous cable can also be sufficiently flexiblein order to accommodate the vertical movement of the second anvil 7060toward and away from the bottom jaw 7030, which is described in greaterdetail further below.

In various embodiments, referring again to FIGS. 228 and 230, the firstanvil 7050 can comprise cam followers 7055 extending therefrom which canbe configured to ride in one or more cam slots, or guide slots, such ascam slot 7070 (FIG. 231), for example, defined in the frame 7041 of thesecond jaw 7040. More particularly, in at least one embodiment, theframe 7041 can comprise a first cam slot 7070 extending longitudinallyalong a first side of the frame 7041 and a second cam 7070 extendinglongitudinally along a second, or opposite, side of the frame 7041,wherein the cam followers 7055 extending from a first side of the firstanvil 7050 can ride in the first cam slot 7070 and the cam followers7055 extending from a second side of the first anvil 7050 can ride inthe second cam slot 7070. In at least one such embodiment, the contoursof each cam slot 7070 can be identical, or at least substantiallyidentical, and can be aligned, or at least substantially aligned, withone another. Similarly, in various embodiments, the second anvil 7060can comprise cam followers 7065 extending therefrom which can beconfigured to ride in the cam slots 7070 (FIG. 231) defined in the frame7041 of the second jaw 7040. More particularly, in at least oneembodiment, the cam followers 7065 extending from a first side of thesecond anvil 7060 can ride in the first cam slot 7070 and the camfollowers 7065 extending from a second side of the second anvil 7060 canride in the second cam slot 7070. In use, the cam followers 7055 of thefirst anvil 7050 and the cam followers 7065 of the second anvil 7060 canslide within the cam slots 7070 such that first anvil 7050 and thesecond anvil 7060 follow the contours of the cam slots 7070 as the firstanvil 7050 and the second anvil 7060 are pulled proximally and/or pusheddistally. In various embodiments, each cam slot 7070 can comprise aplurality of dwell, or upper, portions 7071 and a plurality of driver,or lower, portions 7072 which can be configured to move the anvils 7050and 7060 vertically, i.e., toward and away from the bottom jaw 7030, atthe same time that the anvils 7050 and 7060 are being movedlongitudinally, i.e., between the distal end 7048 and the proximal end7049 of the frame 7041, as described in greater detail further below.

When the surgical stapler 7000 is in an unfired condition, referring toFIG. 231, the first anvil 7050 can be positioned at the distal end 7048of the frame 7041 and the second anvil 7060 can be positioned at theproximal end 7049 of the frame 7041; furthermore, referring now to FIG.232, the staples 6220 positioned in the first jaw 7030 may not yet beinserted into the tissue T and/or the retention matrix positionedthereabove when the surgical stapler 7000 is in an unfired condition. Inuse, referring now to FIG. 233, the staples 6220 can be driven upwardlywithin the staple cavities 7033 of a staple cartridge by the stapledrivers 7012 and, in addition, the first anvil 7050 can be movedproximally from the distal end 7048 of the frame 7041 toward the distalend 7049 in order to engage the staple legs 6221 of the staples 6220. Inat least one embodiment, the staples 6220 can be driven upwardly beforethe first anvil 7050 is engaged with the staple legs 6221 thereof. Invarious embodiments, all of the staples 6220 may be deployed upwardly bythe sled 7010 before the first anvil 7050 is advanced into contact withthe staple legs 6221 or, alternatively, the sled 7010 may be movedproximally at the same time that the first anvil 7050 is movedproximally, although the sled 7010 may sufficiently lead the first anvil7050 in order to deploy the staples 6220 ahead of the first anvil 7050.In various embodiments, as illustrated in FIG. 233, the cam slots 7070can be configured and arranged such that the forming surfaces, such asforming, or camming, surfaces 7053 and 7054, for example, of the firstcam 7050 can contact at least some of the staple legs 6221 when thefirst cam 7050 is passing through a dwell, or upper, position. Invarious circumstances, the cam followers 7055 of the first anvil 7050can each be positioned in a dwell portion 7071 of the cam slots 7070such that the forming surfaces 7053 and 7054 are in a raised positionand such that the staple legs 6221 are only partially deformed when theanvil 7050 passes thereby in the dwell position. As the first cam 7050is moved further along the cam slots 7070, as illustrated in FIG. 234,the cam followers 7055 of the first anvil 7050 can be driven intodriven, or lower, portions 7072 of the cam slots 7070 such that theforming surfaces 7053 and 7054 are moved vertically downwardly towardthe staple legs 6021 in order to drive the staple legs 6021 into theirfinally formed configurations. Thereafter, as the first anvil 7050 isprogressed further along the cam slots 7070, the first anvil 7050 can bedriven vertically upwardly into another set of dwell portions 7071 ofthe cam slots 7070. As illustrated in FIGS. 233 and 234, the reader willnote that the first anvil 7050 may only engage some of the staple legsand not others. In at least one such embodiment, the first anvil 7050can be configured to only deform a group of staple legs comprising thedistal staple legs 6221 of the staples 6220, for example. In at leastone such embodiment, the first anvil 7050 can be configured to deformthe distal staple legs 6221 toward the center of the staples 6220. Invarious embodiments, each proximal staple leg 6221 can be contactedtwice by the first anvil 7050, i.e., by a first forming surface 7053 andby a second forming surface 7054 aligned with the first forming surface7053. In at least one such embodiment, the first forming surfaces 7053can deform the distal staple legs 6221 into a partially-deformedconfiguration when the first anvil 7050 is in a dwell, or upper,position and the second forming surfaces 7054 can deform the distalstaple legs 6221 into a fully-formed configuration when the first anvil7050 is moved into a driven, or lower, position. In various embodiments,referring now to FIGS. 228 and 229, the first anvil 7050 can comprise aplurality of first forming surfaces 7053 and a plurality of secondforming surfaces 7054 in order to deform the distal staple legs 6221 ofstaples 6220 when the staple legs 6221 are arranged in more than one rowor line. In various embodiments, as described in greater detail furtherbelow, the proximal staple legs 6221 of the staples 6020 can be deformedby the second anvil 7060, for example.

In various embodiments, further to the above, the first anvil 7050 canbe moved from the distal end 7048 of the frame 7041 to the proximal end7049 in order to deform all of the distal staple legs 6221 of thestaples 6220. As the reader will note, the first anvil 7050 can be movedup and down relative to the undeformed proximal staple legs 6221 and, inorder to accommodate such relative movement, in various embodiments, thefirst anvil 7050 can comprise one or more clearance slots 7057 (FIG.230) which can be configured to receive the unbent proximal staple legs6221 as the first anvil 7050 bends the distal staple legs 6221.Similarly, referring again to FIG. 228, the second anvil 7060 cancomprise a clearance slot 7067 which can be configured to accommodatethe vertical movement of the first cam actuator 7051 which moves up anddown as the first anvil 7050 is moved between its dwell and drivenpositions as described above. After all of the distal staple legs 6221have been bent, in at least one embodiment, the second anvil 7060 can bemoved from the proximal end 7049 of the frame 7041 to the distal end7048 by the anvil actuator 7061. Similar to the above, referring now toFIG. 235, the cam followers 7065 of the second anvil 7060 can slidewithin the cam slots 7070 such that the second anvil 7060 is movedbetween dwell, or upper, positions and driven, or lower, positions inorder to deform the proximal staple legs 6221 inwardly toward thecenters of the staples 6220, for example. Similar to the above, thesecond anvil 7060 can comprise a plurality of first forming, or camming,surfaces 7063 and a plurality of second forming, or camming, surfaces7064 which can each be configured to at least partially deform and/orcompletely deform one or more of the proximal staple legs 6021.Referring again to FIG. 229, the second anvil 7060 can comprise aplurality of first forming surface 7063 and a plurality of secondforming surfaces 7064 which can be configured to deform the proximalstaple legs 6221 of staples 6220 arranged in a plurality of rows, orlines, for example. As also illustrated in FIG. 229, the first formingsurfaces 7063 and the second forming surfaces 7064 of the second anvil7060 may not be aligned with the first forming surfaces 7053 and thesecond forming surfaces 7054 of the first anvil 7050 wherein, as aresult, the proximal legs 6221 of the staples 6220 may be positioned indifferent rows, or lines, than the distal legs 6221 of the staples 6220.As the reader will also note, the second anvil 7060 can push the firstanvil 7050 as the second anvil 7060 is moved distally. In at least onesuch embodiment, the second anvil 7060 can push the first anvil 7050back into the distal end 7048 of the frame 7041 such that the firstanvil 7050 can be returned to its initial, or unfired, position. Afterall of the proximal staple legs 6221 of the staples 6220 have beendeformed, the second anvil 7060 can be retracted proximally and returnedto its initial, or unfired, position. In this way, the surgical stapler7000 can be reset such that a new staple cartridge can be positioned inthe first jaw 7030 and a new retention matrix can be positioned in thesecond jaw 7040 in order to use the surgical stapler 7000 once again.

In various embodiments, as described above, a surgical stapler cancomprise two or more anvils which can travel longitudinally in order toengage the legs of a plurality of staples in a transverse direction. Incertain embodiments, a surgical stapler can comprise an anvil which ismoved proximally, for example, in order to deform a first group ofstaple legs and distally, for example, in order to deform a second groupof staple legs. In at least one such embodiment, such an anvil cancomprise forming surfaces facing proximally and forming surfaces facingdistally, for example.

In various embodiments, referring now to FIG. 236, an anvil, such asanvil 7140, for example, can comprise a bottom, or tissue-contacting,surface 7141 and a plurality of forming pockets 7142 defined therein. Inat least one embodiment, the anvil 7140 can comprise more than oneplate, such as pocket plates 7143, for example, which can be welded intoa frame 7144. In at least one such embodiment, each pocket plate 7143can be positioned in a plate channel 7145 in the frame 7144 and weldedto the frame 7144 through a weld slot 7146 extending through the frame7144 in order to form a longitudinal weld 7147. In variouscircumstances, the longitudinal weld 7147 can comprise a continuous weldextending along the entire length of the weld slot 7146 or a series ofspaced-apart spot welds extending along the length thereof, for example.In various embodiments, each pocket plate 7143 can comprise two or moreplate portions that have been welded together. In at least one suchembodiment, each pocket plate 7143 can comprise a first plate portion7143 a and a second plate portion 7143 b which can be welded togetheralong a seam 7148. In various embodiments, the first plate portion 7143a and the second plate portion 7143 b of each plate 7143 can be weldedtogether before the plates 7143 are welded into the plate channels 7145in the frame 7144. In at least one such embodiment, the first plateportion 7143 a and the second plate portion 7143 b can compriseco-operating profiles, such as the toothed profiles illustrated in FIG.236, for example, which can be fitted together to form a tight seam7148. In at least one embodiment, each plate 7143 can comprise a heightof approximately 0.02″, for example, which can be taller than the depthof the plate channels 7145 such that the tissue-contacting surfaces 7141thereof extend from the frame 7044 of the anvil 7040. In certainembodiments, referring now to FIG. 237, the plates 7143 can be connectedtogether by at least one weld 7149 at the distal ends of the plates7143, for example.

As illustrated in FIGS. 236 and 237, each pocket plate 7143 can comprisea plurality of forming pockets 7142 defined therein. In variousembodiments, the forming pockets 7142 can be formed in the plates 7143by any suitable manufacturing process, such as a grinding process and/orelectrode-burning process, for example. In at least one such embodiment,referring now to FIGS. 238 and 239, each forming pocket 7142 can bemanufactured by first forming a deep well 7150, then forming an arcuateor curved surface 7151 surrounding the deep well 7150, and then forminga staple leg guide groove 7152 in the curved surface 7151, for example.In various other embodiments, these steps can be performed in anysuitable order. In various embodiments, referring now to FIG. 240, thestaple forming pockets 7142 can be formed such that the inner edges 7153of the forming pockets are separated by a consistent, or at leastsubstantially consistent, gap 7154. In at least one such embodiment, thegap 7154 can be approximately 0.008″, for example. Furthermore, in atleast one such embodiment, the forming pockets 7142 can be positionedalong two or more rows, or lines, the centerlines of which can beseparated by a consistent, or at least substantially consistent, spacing7155. In at least one such embodiment, the spacing 7155 between thecenterlines can be approximately 0.035″, for example. In variousembodiments, referring again to FIG. 240, each forming pocket 7142 cantaper between a narrow width 7156 and a wide width 7157. In at least onesuch embodiment, the narrow width 7156 can be approximately 0.045″ andthe wide width 7157 can be approximately 0.075″, for example. In variousembodiments, the plates 7143 can be comprised of the same material asthe frame 7144. In at least one such embodiment, the plates 7143 and theframe 7144 can both be comprised of stainless steel, such as a 300series or a 400 series stainless steel, for example, and/or titanium,for example. In various other embodiments, the plates 7143 and the frame7144 can be comprised of different materials. In at least one suchembodiment, the plates 7143 can be comprised of a ceramic material, forexample, and the frame 7144 can be comprised of a stainless steel and/ortitanium, for example. In various circumstances, depending on thematerials used, at least one brazing process could be used to secure theplates 7143 in the frame 7144 in addition to or in lieu of the weldingprocesses described above, for example.

In various embodiments, referring now to FIGS. 241-243, an anvil 7240can comprise a frame 7244 and a plurality of pocket plates 7243 whichcan be inserted into the frame 7244. Similar to the above, each pocketplate 7243 can comprise a plurality of forming pockets 7242 definedtherein. In at least one embodiment, the anvil frame 7244 can compriseretention slots 7246 defined therein which can each be configured toreceive a retention rail 7247 extending from a pocket plate 7243. Inorder to assemble the pocket plates 7243 to the anvil frame 7244, theside walls 7245 of the anvil frame 7244 can be flexed or splayedoutwardly, as illustrated in FIG. 242, in order to widen the retentionslots 7246 such that each retention slot 7246 can receive a retentionrail 7247 of a pocket plate 7243 therein. Once the retention rails 7247have been positioned in the retention slots 7246, the side walls 7245can be released, as illustrated in FIG. 243, thereby allowing the frame7244 to resiliently contract and/or return to its unflexed state. Insuch circumstances, the retention slots 7246 can contract and therebycapture the retention rails 7247 therein. In certain embodiments, theretention rails 7247 and/or the retention slots 7246 can comprise one ormore co-operating tapered surfaces which, after the flexed retentionslots 7246 have been released, can form a taper-lock engagement whichcan retain the retention rails 7247 in the retention slots 7246. Similarto the above, the pocket plates 7243 can be comprised of the samematerial as or a different material than the frame 7244. In at least onesuch embodiment, the plates 7243 can be comprised of a ceramic material,for example, and the frame 7244 can be comprised of a stainless steeland/or titanium, for example. In various circumstances, depending on thematerials used, at least one brazing process and/or at least one weldingprocess, for example, could be used to secure the plates 7243 in theframe 7244.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

While this invention has been described as having exemplary designs, thepresent invention may be further modified within the spirit and scope ofthe disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this invention pertains.

1. A surgical instrument, comprising: a handle assembly; and anelongated shaft assembly operably coupled to said handle assembly, saidelongated shaft assembly having a distal end couplable to an endeffector that supports a staple cartridge that has a plurality ofunformed staples therein and an anvil that is movable from an openposition wherein a staple forming surface of the anvil is spaced fromthe staple cartridge into forming engagement with the staples thereinwherein a distance that the staple forming surface of the anvil travelsinto forming contact with the staples in the staple cartridge isdependent upon a magnitude of firing force applied thereto by a firingsystem that is at least partially supported in said elongated shaftassembly and said handle assembly and operated by a firing triggermovably supported on the handle assembly such that said magnitude offiring force applied to said movable anvil is dependent upon a degree inwhich the firing trigger has been actuated on the handle assembly. 2.The surgical instrument of claim 1 wherein said elongated shaft assemblyfurther comprises an elongated spine member operably attached to saidhandle assembly and protruding therefrom, said elongated spine memberhaving a distal end that is removably couplable to the end effector andwherein said firing system comprises a firing tube movably supported onsaid spine member and interfacing with said firing trigger such thatsaid actuation of said firing trigger causes said firing tube to movedistally on said spine member.
 3. The surgical instrument of claim 2wherein a distal end of said firing tube is configured to engage theanvil such that said magnitude of said firing force is increased as saiddistal end of said firing tube moves distally into engagement with saidanvil.
 4. The surgical instrument of claim 3 wherein the anvil has ananvil ramp portion and wherein said magnitude of firing force increasesas the distal end of the firing tube advances distally in compressingengagement with said anvil ramp portion.
 5. The surgical instrument ofclaim 4 wherein said anvil ramp portion has a proximal ramp surface anda clamping ramp surface that is oriented at a clamping angle relative tosaid proximal ramp surface such that as said distal end of said firingtube engages said clamping ramp surface, said anvil is driven into aclamping orientation wherein tissue may be clamped between the anvil andthe staple cartridge without forming any staples in the staplecartridge.
 6. The surgical instrument of claim 4 wherein said anvil rampportion further has a staple forming ramp surface thereon that is at aforming angle that differs from said clamping angle and wherein whensaid distal end of said firing tube engages said staple forming rampsurface, said staple forming portion of said anvil is driven intoforming contact with the staples in the staple cartridge.
 7. Thesurgical instrument of claim 1 wherein said firing trigger is pivotallysupported by said handle assembly and is selectively pivotable relativeto a pistol grip portion thereof.
 8. The surgical instrument of claim 1wherein the anvil is biased to the open position prior to activation ofsaid firing trigger.
 9. The surgical instrument of claim 1 wherein saidelongated shaft operably supports a cutting member therein that isindependently actuatable from said firing system.
 10. The surgicalinstrument of claim 1 wherein a degree of staple formation attained byeach staple in the staple cartridge is dependent upon the magnitude offiring motion applied to the anvil by said firing system.
 11. An endeffector for use in connection with a surgical instrument, said endeffector comprising: an elongated channel couplable to a portion of thesurgical instrument; a staple cartridge removably supported within saidelongated channel, said staple cartridge comprising a plurality ofunformed staples supported within a compressible material; and an anvilmovably coupled to said elongated channel and having a staple formingsurface thereon, said anvil configured to move from an open positionwherein said staple forming surface is spaced from said staple cartridgeinto compressing contact with said staple cartridge in response to amagnitude of firing motion applied thereto by the surgical instrumentsuch that as the magnitude of the firing motion increases, said stapleforming surface is further compressed into said staple cartridge intostaple forming contact with the staples therein.
 12. The end effector ofclaim 11 wherein a degree of staple formation attained by each saidstaple is dependent upon the magnitude of firing motion applied to saidanvil by the surgical instrument.
 13. The end effector of claim 12wherein said staples are simultaneously formed with a substantiallysimilar amount of formation.
 14. The end effector of claim 11 whereinsaid anvil is biased to said open position.
 15. The end effector ofclaim 11 wherein said anvil has an anvil ramp portion and wherein saidmagnitude of firing force increases as a firing portion of the surgicalinstrument advances distally in compressing engagement with said anvilramp portion.
 16. The end effector of claim 15 wherein said anvil rampportion has a proximal ramp surface and a clamping ramp surface that isoriented at a clamping angle relative to said proximal ramp surface suchthat as the firing portion of the surgical instrument engages saidclamping ramp surface, said anvil is driven into a clamping orientationwherein tissue may be clamped between the anvil and the staple cartridgewithout forming any staples in the staple cartridge.
 17. The endeffector of claim 16 wherein said anvil ramp portion further has astaple forming ramp surface thereon that is at a forming angle thatdiffers from said clamping angle and wherein when the firing portion ofthe surgical instrument engages said staple forming ramp surface, saidstaple forming portion of said anvil is driven into forming contact withthe staples in the staple cartridge.
 18. A surgical instrument,comprising: a handle assembly; a spine member operably coupled to saidhandle assembly and having a distal end; an elongated channel couplableto said distal end of said spine member; a staple cartridge removablysupported within said elongated channel and operably supporting aplurality of unformed staples therein; an anvil movably coupled to saidelongated channel and having a staple forming surface thereon, saidanvil configured to move from an open position wherein said stapleforming surface is spaced from said staple cartridge into compressingcontact with said staple cartridge in response to a magnitude of firingmotion applied thereto such that, as the magnitude of the firing motionincreases, said staple forming surface is further compressed into stapleforming contact with the staples in said staple cartridge; a firing tubemovably supported on said spine member and having a distal endconfigured for engagement with said anvil such that said magnitude ofsaid firing force is increased as said distal end of said firing tubemoves distally into engagement with said anvil; and a firing triggerpivotally supported on said handle assembly and interfacing with saidfiring tube such that said firing tube is moved distally on said spinemember as said firing trigger is pivoted.
 19. The surgical instrument ofclaim 18 wherein said staples are supported within said staple cartridgesuch that as said anvil is moved into said forming contact therewith,said staples remain substantially stationary within the staplecartridge.
 20. The surgical instrument of claim 18 wherein said staplesare supported in a substantially compressible hemostatic material.